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Defibrillation electrodes for children - electrodes older than 2 years may malfunction
(Leonhard Lang) Electrodes older than 2 years may malfunction and this could delay urgent treatment. (MDA/2015/009)
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Breathing system components - risk of interruption to anaesthesia and/or ventilation
(Inmed, supplied by Teleflex) Risks due to cracks in the corrugated flex tube - manufacturer is recalling affected devices. (MDA/2015/008)
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Recall of Vyclic Colour 3-way stopcock 2FL/1M: risk of sterility being affected
(Vygon) The paper side of the primary packaging could be punctured compromising sterility, manufacturer is recalling the devices. (MDA/2015/007)
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Consent decree for medical devices supplied by Atrium Medical (Maquet)
(Atrium Medical subsidiary of Maquet) Guidance for healthcare professionals who have received a Food and Drug Administration (FDA) consent decree from Maquet about its subsidiary Atrium Medical. (MDA/2015/006)
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CEM™ nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator - risk of burns
(Integra LifeSciences) Risk of burns to user if the blue COAG button on the CUSA Excel CEM nosecone sticks in the ‘activated’ position. (MDA/2015/005)
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Reissue: endobronchial tubes - potential failure to ventilate the patient if Cobb connector detaches from main connector
Reissued – ‘Problem’ section removed: (Teleflex Medical) Could lead to hypoxia and hypercarbia if not immediately detected and corrected. (MDA/2015/004R)
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Endobronchial tubes - potential failure to ventilate the patient if Cobb connector detaches from main connector
(Teleflex Medical) Could lead to hypoxia and hypercarbia if not immediately detected and corrected. (MDA/2015/004)
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Renasys™ negative pressure wound therapy range - risk of maceration, infection, loss of negative pressure or unrecognised bleeding in wounds
(Smith & Nephew Healthcare Limited) Risk of maceration, infection, loss of negative pressure or unrecognised bleeding in wounds if there is a blockage in the vacuum system of affected devices (MDA/2015/003)
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HomeChoice and HomeChoice PRO automated peritoneal dialysis system - added to and updated warnings and cautions
(Baxter Healthcare Ltd) Various changes to the ‘Patient At-Home Guide’ warnings relate to both identifying patient fluid retention and the general safe operation of the product (MDA/2015/002)
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Insulin infusion pump - risk of hyperglycaemia or hypoglycaemia
(Roche Diagnostics Ltd) Risk of hyperglycaemia or hypoglycaemia if the pump’s power is interrupted (MDA/2015/001)
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Oral diclofenac presentations with legal status ‘P’ – reclassified to POM
(Novartis Consumer Health UK Limited and Actavis Group PTC EHF): Product reclassified from P to POM due to safety concerns – class 2 action within 48 hours (EL (15)A/01)
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Toshiba ultrasound transducers - counterfeit ultrasound transducers supplied to 2 hospitals
Users should check Toshiba ultrasound transducers not supplied direct from Toshiba Medical Systems UK. (MDA/2014/046)
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Multicath Expert 5 Lumen (9.5FG/16cm) - risk of incorrect placement of catheter
(Vygon) Due to a manufacturing problem the catheter tip may not reach the desired position during placement and some may have 4 lumens instead of 5. (MDA/2014/045R)
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IW900-series infant warmers - risk of serious injury to the infant in the warmer
(Fisher and Paykel Healthcare) Heater head may partially detach due to manufacturing fault if the nut securing the heater head breaks. (MDA/2014/048)
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Ebixa 5mg/pump actuation 50ml and 100ml bottle - fault with some of the pump devices
(Lundbeck Limited) May result in suboptimal dosage of the product - class 2 action within 48 hours. (EL (14)A/19)
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Autopen insulin pen injection devices - risk of hyperglycaemia
(Owen Mumford Ltd) Affected devices may have a mechanical fault which could cause the dose selector to revert to zero, which results in the devices not delivering the correct dose of insulin. (MDA/2014/047)
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Mains power lead used with Omnifuse syringe pumps (part number 0151-0651) - quarantine affected leads
(Smiths Medical International Ltd. - all models) incorrect design of the mains lead causes a risk of interruption or delay in therapy. (MDA/2014/044)
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Gel-E Donut and Squishon 2 neonatal and paediatric support devices - risk of infection, breathing difficulties and allergic reactions
(Philips Healthcare (Children’s Medical Ventures)) Mould growth on these neonatal and paediatric support devices. (MDA/2014/043)
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Hudson RCI© nebulizer adaptors and Aquapak sterile water with nebulizer adaptors - identify and quarantine affected devices
(Teleflex Medical) Risk of the packaging not being sealed properly. (MDA/2014/042)
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Babytherm infant warmers and open infant care units for newborns - identify affected devices and read latest information
(Draeger Medical) Risk of baby falling out of the device. (MDA/2014/041)
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Amoxil Vials for injection 500mg and 1g, Augmentin Intravenous 600mg and 1.2g - cracks in vials used for packaging
(GlaxoSmithKline) Check each vial for cracks by turning upside down and looking for chips, cracks or damage where base meets side wall. (EL (14)A/15)
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LIFEPAK® 1000 defibrillator - risk of failure to deliver a shock
(Physio-Control) Due to unexpected shut down of the defibrillator caused by a battery with very low charge. (MDA/2014/040)
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TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) - identify patients affected recently
(Boston Scientific) Rapid battery depletion leads to risk of loss of therapy. (MDA/2014/039)
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All medical devices - ensure system is in place to distribute field safety notices (FSNs)
(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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Portex® endotracheal tube holder (2.5mm and 3.0mm) - risk of extubation or delay to therapy
(Smiths Medical) May be difficult passing a suction catheter through the endotracheal tube when the holder is locked. (MDA/2014/036)
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Ellipse™ VR/DR implantable cardioverter defibrillators (ICDs) - potential failure mode
(St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.(MDA/2014/035)
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Motilium 10 10mg Tablets and Motilium Instants10mg – changed to prescription-only medicine
(McNeil Products Limited) Remaining stocks of the above products should be quarantined - class 2 action within 48 hours. (EL (14)A/14)
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Basin/bowl liner or equipment cover (drape) - risk of small cracks or holes
(Microtek Medical) Could compromise the sterile field. (MDA/2014/034)
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Gastrostomy devices - risk of infection
(Medicina Ltd) balloon gastrostomy kit may contain out-of-date devices. (MDA/2014/032)
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Insulin syringe 1ml safety syringe 27G - unable to deliver fewer than 7 units of insulin
(Greatbatch) CE marking invalid - Do not use affected devices. (MDA/2014/033)
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Idarubicin 1mg/ml injection 5 & 10 ml - recall
(Teva UK Limited) red precipitate found during stability testing under cold storage conditions - class 2 action within 48 hours. (EL (14)A/13)
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Buccolam Oromucosal Solution - possibility for chemical contamination
(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
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Standard offset cup impactor - potential for infection
(Greatbatch) Infection from inadequately sterilized devices. (MDA/2014/031)
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Synthes trauma external fixation system - change in instructions for use
(DePuy Synthes) Change places additional restrictions on patient positioning. (MDA/2014/030)
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Amoxicillin Sodium 500mg Powder for Solution for Injection - additional reports of injection site reactions in paediatrics and adults
(Wockhardt UK Ltd) Remaining stock from affected batches should be quarantined and returned to the original supplier for credit - class 2 action within 48 hours. (EL (14)A/11)
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Ventstar disposable breathing systems - potential for loose adhesive residue
(Draeger) Adhesive residue may enter the lungs. (MDA/2014/029)
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Midazolam Buccal Liquid 10mg / 1ml, 5ml - screw caps not been correctly placed
(Penn Pharma, distributed in Quantum Pharmaceutical livery) May result in evaporation of aqueous component of product and increase in concentration of Midazolam. (EL (14)/A10)
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Procedure packs containing various central venous catheters - risk of incorrect lumen selection
(Arrow International - a division of Teleflex) Issued as an update to MDA/2014/022. (MDA/2014/028)
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Breast implants - report cases of anaplastic large cell lymphoma (ALCL)
(All types, makes and models) Report cases in women who have breast implants or who have had them removed. (MDA/2014/027)
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Accu-Chek home use blood glucose meters - falsely low blood glucose readings
(Roche) May give falsely low blood glucose readings for patients receiving ceftriaxone therapy. (MDA/2014/026)
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Amoxicillin Sodium 250mg, 500g, & 1mg powder for solution for injection - reports of extravasation and injection site reactions
(Wockhardt UK Ltd) Should not be used in neonates and infants under 1 year old until further notice. (EL (14)A/09)
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ReTurn 7400 and ReTurn 7500 turning aids - risk of injury due to wing handles coming loose
(Handicare AB) Wing handle on ladder part of the turning aid may become loose. (MDA/2014/025)
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HeartStart MRx defibrillators/monitors - risk of delay in delivering CPR
(Philips) When HeartStart MRx is used with Q-CPR meter in defibrillation mode, meter may incorrectly display ‘Do Not Touch the Patient’ icon. (MDA/2014/024)
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Fybogel Hi-Fibre and Fybogel Orange - potential risk of contamination with metal particles
(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock of batches should be quarantined and returned to original supplier for credit. - class 2 action within 48 hours. (EL (14)A/08)
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Clarithromycin 500mg Powder for Solution for Infusion - small particles of white material to be present in individual vials
(Mylan on behalf of Strides Arcolab International Limited) Remaining stocks of affected batches should be quarantined - class 2 action within 48 hours. (EL (14)A/07)
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Adaptors for Shelfpak humidifier and Aquapak sterile water - risk of packaging not being sealed properly
(Teleflex Medical) Return affected devices and arrange for replacements. (MDA/2014/023)
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Central venous catheters - extension lumen may have the wrong exit and size printed on it
(Arrow International - a division of Teleflex) Use the Arrow’s hub colour coding as a guide, not what is printed on the lumen. (MDA/2014/022)
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Vancomycin Powder for Concentrate for Solution for Infusion - small particles of fibre material and glass in individual vials
(ITH Pharma Ltd) Remaining stocks should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/06)
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Accu-Chek home use blood glucose meters - may give falsely high readings
(Roche) Could result in patients taking an inappropriately high dose of insulin. (MDA/2014/021)
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Lipid Phase only of Parenteral Nutrition - potential contamination with Bacillus cereus
(ITH Pharma Ltd) Small number of reported cases of bacillus cereus septicaemia affecting neonates - class 1 action now. (EL (14)A/05)
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Heated humidifiers used in combination with heated-wire breathing systems - risk of oxygen-fuelled fire
(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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Paradigm ambulatory insulin infusion pumps - risk of hypoglycaemia
(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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Unicondylar sled knee prosthesis - risk of early wear
(Waldemar Link GmbH & Company.KG) Consider annual review of patients for up to 5 years after implantation, including X-rays to detect progression of bearing wear. (MDA/2014/018)
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Alaris® SmartSite® needle-free valve - risk of delay to treatment
(CareFusion) Risk of disconnection or inability to disconnect from the SmartSite. (MDA/2014/017)
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Reusable latex breathing bags - potential for acute allergic reactions
(Dräger) Follow local procedures for latex. (MDA/2014/016)
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All Pace Medical Inc temporary pacemakers and pacing system analysers (PSAs) – CE marking suspended
(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
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Samaritan® public access defibrillator - may miscalculate the cardiopulmonary resuscitation (CPR) rate
(HeartSine Technologies) Rescuer may be incorrectly advised by the device to ‘Push Slower’ when CPR rate is actually at an acceptable level. (MDA/2014/014)
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S74 Elite Sport Scooter with Leoch 20 amp/hour batteries - risk of scooter batteries overheating and swelling during charging cycle
(Pride Mobility Ltd) May result in reduced range of travel or failure to drive as expected. (MDA/2014/013)
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Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser
(Made by Hitachi, supplied by Roche) Use of insufficient volumes of reagent may lead to a false negative result and a missed diagnosis. (MDA/2014/012)
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Powered wheelchairs - risk of injury
(Pride Mobility Products Ltd) Risk of injury should powered wheelchairs be secured into vehicles incorrectly. (MDA/2014/011)
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FreeStyle Mini® and FreeStyle® blood glucose monitoring systems – risk of incorrect results
(Abbott Diabetes Care) May give incorrect low blood glucose results used with FreeStyle Lite and FreeStyle blood glucose test strips. (MDA/2014/009)
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GemStar infusion system - risk of delay to patient therapy
(Hospira) Connection between beeper subassembly and pump may fail so only visual alarms are available. (MDA/2014/010)
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Fybogel Orange - risk of contamination with metal particles
(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/04)
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Insulin infusion pump - risk of delay in treatment
(Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component. (MDA/2014/008)
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Viread 245 mg Film-Coated Tablets - possible presence of silicone rubber
(Gilead Sciences Limited) Pharmacists should quarantine any remaining stocks affected batches and return them to the original wholesaler for credi - class 2 action within 48 hours. (EL (14)A/03)
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Peristeen anal irrigation system - risk of using transanal irrigation inappropriately
(Coloplast Limited) Instructions for use have been updated. (MDA/2014/007)
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CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator - risk of burns
(Integra Lifesciences) Blue COAG button on the CUSA® Excel CEM™ nosecone could stick in the ‘activated’ position. (MDA/2014/006)
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Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 - risk of injury
(Carestream Health) Risk of injury if joint between scissor arm and bracket fails. (MDA/2014/005)
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COSOPT preservative-free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container - difficulties with administration
(Merck Sharp and Dohme) Increase in the number of adverse events and product complaints following introduction of ‘winged’ presentation - class 2 action within 48 hours. (EL (14)A/02)
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Counterfeit or non-CE marked dental medical devices
(All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)
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Plastipak 50ml Luer Lok single-use syringes - risk of delay or interruption to treatment
(BD Medical) Occlusion alarms triggering due to an increased plunger movement force. (MDA/2014/003)
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Irbesartan / Hydrochorothiazide Teva 300/12.5mg and 300/25mg film-coated tablets - incorrect dosing instruction in patient information leaflet
(Teva UK Ltd) Leaflet incorrectly states take 1 or 2 tablets a day. (EL (14)A/01)
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VitreaCore® Workstation software for computed tomography systems - risk of patient misdiagnosis or inappropriate treatment
(Vital Images) Incorrect image orientation marking when loading a study into the 3D viewer. (MDA/2014/002)
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OPTEASE® retrievable vena cava filter - risk of serious patient injury
(Cordis Corporation) Risk from the migration of a wrongly orientated inferior vena cava (IVC) filter. (MDA/2014/001)
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Irbesartan 300mg film-coated tablets - blisters is incorrectly labelled as Irbesartan 150mg
(Accord Healthcare Limited) Recipients should quarantine any remaining stock and return it to supplier for credit - class 2 action within 48 hours. (EL (13)A/32)
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GemStar docking station for use with specific GemStar infusion pumps - potential for delay in infusion therapy
(Hospira) May fail to power up or configuration could generate an error code, stopping a running infusion. (MDA/2013/085)
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Implantable pacemakers - residual longevity overestimated
(Sorin) Difference between predicted and actual pacemaker battery depletion characteristics. (MDA/2013/084)
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Pressure reducing air mattresses – silicone oil may leak
(Hill-Rom) Oil may leak out of the pressure sensor of the mattress and spill onto the floor resulting in slips and injury. (MDA/2013/086)
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Methotrexate 25mg/ml Injection - damaged vials
(Teva UK Limited) Damaged vials so potential for a lack of sterility assurance - class 2 action within 48 hours. (EL (13)A/31)
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Tixylix® liquid medicines - small pieces of plastic being found in medicine
(Novartis Consumer Health UK Ltd) Fault with tamper seal on might result in small pieces of plastic being found in medicine.
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TransRadial artery access kit - risk of delay to treatment
(Arrow International) Introducer needles packaged within the kits can be partially or fully occluded. (MDA/2013/083)
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Class 4 Drug Alert (Caution in Use): Matrifen 100 micrograms/hour Transdermal Patch, Teva UK Livery - Takeda UK Limited (EL (13)A/29)
Takeda UK Limited has informed us that there is an error in the text on the pouch for batches of Matrifen 100 micrograms/hour Transdermal Patches distributed since 25 May 2013 in Teva UK livery.
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Jext 300 and 150 micrograms solution for injection in pre-filled pens - problem with delivery of dosage
(ALK-Abelló A/S) Potential problem with delivery of dosage following activation of auto injector.
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Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG - PL 03551/0069
This alert has been issued as B.
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Intravenous pump set - risk of embolism and allergic reaction
(Hospira) Due to exposure to particulates and non-biocompatible materials, especially during administration of parenteral lipids. (MDA/2013/081R)
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Perfusor Space infusion pump - risk of interruption of therapy when changing syringe
(B Braun) If battery of 4 years or older is used, pump may not have sufficient power to perform a syringe change. (MDA/2013/080)
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Intravenous administration sets, Primary PlumSet Clave secondary port - risk of interruption to IV therapy
(Hospira) Due to the breakage of the bond between Clave connector and secondary port of the PlumSet. (MDA/2013/079)
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Plum A+ and A+3 family of infusers, Gemstar infuser and Lifecare PCA infuser - CE marking withdrawn
(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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Receptal suction canisters and liners - potential for failure or loss of suction
(Microtek Medical Europe) Failure or loss of suction if a canister and liner of different sizes are used in combination. (MDA/2013/077)
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Imigran Injection/Subject - syringes may have needles protruding from the needle shield
(GlaxoSmithKline UK) Remaining stocks of the affected batch should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/26)
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NovoMix 30 Penfill 100U/ml, 3ml and NovoMix 30 FlexPen 100U/ml, 3ml – cartridges contain too much or too little insulin in batches
(Novo Nordisk A/S) Patients who may have received the affected batches should be contacted and asked to check their supply – class 2 action within 48 hours. (EL (13)A/25)
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Ultrasound probe cover - increased risk to users of exposure to endotoxin levels
(Microtek Medical Europe) Exposure to levels above acceptable limits if ultrasound probe cover comes into contact with the central nervous system. (MDA/2013/076)
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Multiple products by Wockhardt UK Limited – 2nd site certificate withdrawn
(Morningside Healthcare Limited) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. – class 2 action within 48 hours. (EL (13)A/24)
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Vacutainer® multiple sample Luer adaptor for blood sample collection - risk of exposure to blood under filling blood collection tubes
(Becton, Dickinson and Company (BD)) Could lead to unexpected results in some laboratory tests. (MDA/2013/075)
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BD Neoflon IV cannula - risk of delay in treatment
(Becton Dickinson) Due to increased risk of the catheter buckling during initial puncture of skin. (MDA/2013/074)
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Pressure relieving air mattresses and overlays – risk of fire
(All models and manufacturers) Reports of lit cigarettes dropped onto non-fire-retardant bedding resulting in breach of the mattress or overlay material and leakage of pumped air aided combustion. (MDA/2013/073)
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Natzon 0.4mg Sublingual Tablets - wrong blister packs in cartons
(Morningside Healthcare Limited) Small number of blisters containing Buprenorphine 8mg Sublingual Tablets packed in cartons labelled Natzon 0.4mg Sublingual Tablets – class 2 action within 48 hours. (EL (13)A/23)
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Bydureon 2mg powder and solvent - may contain small number of under-filled vials
(Eli Lilly Nederland B.V.) Remaining stocks of affected batch should be quarantined and returned to original supplier for credit – class 2 action within 48 hours. (EL (13)A/22)
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NordiPen® - risk of under-dosing
(Novo Nordisk) Device may not fully screw together. (MDA/2013/071)
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Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps - risk of under- or over-delivery of insulin
(Medtronic) May lead to hypoglycaemia or hyperglycaemia, with a consequent loss of consciousness or death, in extreme cases. (MDA/2013/070)
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PlastipakTM 50ml Luer Lok syringe - risk of under-delivery of medication
(BD Medical) Syringes from affected batches may have a dent/indentation on the syringe barrel which may cause leakage inside the syringe, between the plunger and the barrel. (MDA/2013/068)
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Protect-A-Line IV extension set (supplied with vented caps) - risk of air embolus
(Vygon) Affected devices have been supplied with vented caps on the female port (Y-site) instead of non-vented capss. (MDA/2013/067)
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HeartStart XL defibrillator/monitor - battery life and capacity test interval reduced
(Philips) Battery life reduced from 1.5 years to 1 year and capacity test interval reduced from 6 months to 3 months. (MDA/2013/066)
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GlucoMen LX Sensor blood glucose test strips – lots contaminated during manufacture
(Menarini) May give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. (MDA/2013/064)
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TRACOE twist tracheostomy tubes - risk of delay in treatment
(Manufactured by TRACOE Medical, distributed in the UK by Kapitex Healthcare Ltd) Due to difficulty changing the inner cannula as the locking system can be too tight. (MDA/2013/063)
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Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails - risk of interruption to therapy
(CareFusion) Pump may stop, alarm and display a ‘DRV1’ or ‘DRV2’ error on the screen. (MDA/2013/062)
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Warfarin 3mg tablets - higher than expected levels of degradation
(Teva UK Limited) Remaining stock should be quarantined and returned to original supplier for credit – class 3 action within 5 days. (EL (13) A/21)
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Wheeled and non-wheeled walking frames (all models) - potential for detachment of the wheels and/or inadequately tightened screws
(Patterson Medical) May cause the user to fall. (MDA/2013/060)
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Vacutainer® multiple sample Luer adaptor for blood sample collection - increased risk of exposure to blood and underfilling blood collection tubes
(Becton, Dickinson and Company (BD)) Could lead to unexpected results in some laboratory tests. (MDA/2013/061)
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Flexible handle used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI)
(Synthes GmbH) Device may not be adequately cleaned when using the flexible handle (part no. 355.280). (MDA/2013/059)
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Blood grouping cassettes - labels containing product information on the wrong side of the cassette
(Ortho Clinical Diagnostics) May lead to false negative or false positive results. (MDA/2013/058)
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Spectra series powered wheelchairs - potential for components to overheat
(Invacare) Overheating in the event of a stall condition. (MDA/2013/057)
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Protect-A-Line extension set - risk of false occlusion alarms and interruption to therapy
(Vygon) Due to new anti-syphon valve which may require adjustment of infusion pump occlusion alarm settings to avoid false occlusion alarms. (MDA/2013/056)
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Days walking stick (Model 404) - handle can crack
(Patterson Medical Ltd) May cause the user to fall. (MDA/2013/055R)
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SLE 4000/5000 ventilator, power supply unit (PSU) model FP110-410 - potential component failure
(SLE) Could cause the ventilator to alarm and shut down immediately. (MDA/2013/052)
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Multiple products by Wockhardt UK Limited – certificate for manufacturing site withdrawn
(Wockhardt UK Limited) Remaining stocks of affected batches should be quarantined and returned to original supplier for credit – class 2 action within 48 hours (EL (13)A/19)
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HeartStart MRx Monitor/Defibrillator –possible failure to deliver defibrillation therapy
(Philips Healthcare) May fail to deliver defibrillation therapy in either “Manual Defib”, “AED” or “Sync Cardioversion” mode. (MDA/2013/052)
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Erythromycin Oral Suspension – manufacturers certificate withdrawn
(Pinewood Laboratories Limited) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/18)
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Biplane cardiovascular X-ray system (Floor Mounted) - risk of interruption in treatment/procedure
(Philips) Motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm. (MDA/2013/045R)
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Overhead and Mobile Patient Hoists - risk of serious injury to a patient, caregiver or bystander
(Liko (A Hill-Rom Company)) Risk could result from tripping or falling on to the sling bar. (MDA/2013/051)
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Ibis Comfort wheelchair - upper hinge block component used in the tilt mechanism may break
(Handicare B.V.) Could cause the seat unit to tip backwards unexpectedly. (MDA/2013/049)
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Suction canisters and liners - potential loss of suction
(Hospira (formerly manufactured by Abbott)) Seek alternative devices immediately and return affected devices to the manufacturer. (MDA/2013/048)
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Hydroxyethyl starch (HES) products - increased risk of renal dysfunction and mortality
(B Braun Melsungen AG and Fresenius Kabi Limited) Increased risk of renal dysfunction and mortality in critically ill or septic patients– class 1 action within 48 hours. (EL (13)A/18)
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Safety blood collection and infusion sets - risk of leakage of blood or infusion fluid, or under-filling of evacuated blood collection tubes or blood culture bottles
(Greiner Bio-One) Due to potential cracking of the Luer connector. (MDA/2013/047)
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Biplane cardiovascular X-ray system - risk of interruption in treatment/procedure
(Philips) Table will reboot if users attempt a powered and manual movement at the same time. (MDA/2013/045)
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Rad-8 Pulse Oximeter with 20-pin patient cable connector - risk of delay in treatment
(Masimo) Stop using and quarantine these pulse oximeters. (MDA/2013/043)
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Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS - incorrectly etched screw size
(Synthes GmbH) Could lead to clinical complications including dural injury, bleeding and failure of fracture fixation. (MDA/2013/044)
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Laboratory test kit for vitamin B12 malabsorption – risk of false negative results
(Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics) Deterioration in the activity of affected lots may lead to false negative results and a delay in treatment. (MDA/2013/041)
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Implantable drug pumps and accessories - risk of drug under- or overdose
(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)
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AmBisome 50mg Powder for Solution for Infusion - potential lack of sterility assurance
(Gilead Sciences International Limited) Remaining stocks of affected batches should be quarantined and returned to the original supplier for credit – class 1 action now. (EL (13)A/17)
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Laboratory test kit - possibility of false positive results
(Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics) Possibility of false positive results in tests for the diagnosis of lupus. (MDA/2013/040)
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Ventolin Syrup sugar-free 2mg in 5ml - risk of glass fragments in the bottles
(Glaxo Wellcome UK Ltd) Source of possible contamination is believed to be sucrose used within this formulation of Questran – potential risk of glass fragments in bottles due to defect identified in very small number of bottles – class 2 action within 48 hours. (EL (13)A/16)
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Workstation software for computed tomography systems: Vitrea CT Brain Perfusion 2D application
(Vital Images, Inc) Risk of patient misdiagnosis, inappropriate treatment or treatment delay due to incompatibility of software with certain protocols or CT units. (MDA/2013/039)
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Rusch Belly Bag urine collection bag with hip belt - risk to sterility due to compromised packaging
(Teleflex Medical) Contact patients who have received affected stock and retrieve any unused devices. (MDA/2013/038)
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Questran 4g sachet Powder for Oral Suspension - possible contamination with Enterococcus faecium
(Bristol-Myers Squibb Pharmaceuticals Limited) Source of possible contamination is believed to be sucrose used within this formulation of Questran – class 2 action within 48 hours. (EL (13)A/15)
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SERVO-i ventilator system battery modules - risk of early or unexpected loss of ventilation
(Maquet) Due to certain battery modules having shorter than specified run time. (MDA/2013/037)
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MICRO-PACE REF 4580 - return to market
(Pace Medical and distributed in UK by APC Cardiovascular) Ensure continued, heightened vigilance in monitoring. (MDA/2013/036)
-
Paradigm ambulatory insulin infusion pumps - risk of compromised insulin therapy
(Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (MDA/2013/035)
-
RÜSCH Macintosh laryngoscopes - potential for light to flicker or fail
(M.A.
-
Diacap® Ultra dialysis fluid filter - risk of a gradual increased fluid removal
(B.
-
Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - risk of inadequate external pacing
(All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)
-
Dynamis and Gerialit with Dewert electrical control systems - risk of serious injury
(Hill-Rom) Unintentional movement, including sudden collapse to its lowest position, can occur when the bed is connected to the mains supply. (MDA/2013/031)
-
Reinforced endotracheal tubes - affected tubes may delaminate
(Unomedical (a ConvaTec company)) Can lead to constriction of the lumen, resulting in a reduction of airflow to the patient. (MDA/2013/029)
-
Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of the syringe label
(Aurum Pharmaceuticals Limited (trading as Martindale Pharma)) Replaces drug alert issued on 29 April 2013 (EL 13(A)13 Rev 1)
-
Retrievable inferior vena cava (IVC) filters - serious complications associated with attempted IVC filter retrieval
(All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)
-
Ativan Injection 4mg/ml - glass particles identified
(Pfizer Limited) Very small number of ampoules containing glass particles identified – class 3 action within 5 days. (EL (13)A/14)
-
1 litre suction canisters and liners - potential failure or loss of suction
(Hospira (formerly manufactured by Abbott)) Seek alternative devices immediately and return affected devices to the manufacturer. (MDA/2013/026)
-
FreeStyle InsuLinx home use blood glucose meter - incorrect low test result
(Abbott Diabetes Care) At extremely high blood glucose levels of 56.8 mmol/L and above meter will display and store in its memory an incorrect low test result. (MDA/2013/025)
-
Peritoneal dialysis transfer sets – risk of contamination
(Baxter Healthcare Ltd) Improper use may result in contamination leading to infection or peritonitis. (MDA/2013/027)
-
Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of syringe label
(Aurum Pharmaceuticals Limited (trading as Martindale Pharma)) Pre-filled syringes from affected batches should be used with caution.– class 3 action within 5 days. (EL 13(A)13)
-
Diazepam 2mg Tablets - does not comply with the required specification
(Teva UK Limited) results of assays carried out during routine stability studies did not comply with the required specification – class 3 action within 5 days. (EL 13(A)11)
-
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX - risk of measurement error
(LifeScan) Risk when images are rotated at the time of reconstruction. (MDA/2013/023)
-
Lifescan OneTouch Verio Pro; Lifescan OneTouch Verio IQ - software fault
(LifeScan) Fault at glucose levels of 56.8mmol/l and above. (MDA/2013/022)
-
Miacalcic 200 IU Nasal Spray Solution - withdrawn throughout the European Union
(Novartis Pharmaceuticals UK) Increased risk of malignancies with long -term use of calcitonin – class 2 action within 48 hours. (EL 13(A)11)
-
Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces
(All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)
-
Acrobat Swing (AC Swing) arm - risk of injury from detachment of the swing arm
(Ondal) After approximately 7 years of use, the plastic spigot joint of swing arm can fail through fatigue. (MDA/2013/020)
-
Infusion pump: Alaris® GP volumetric pump - risk of embolism
(CareFusion) Identify affected devices and ensure staff are aware of manufacturer’s advice. (MDA/2013/017)
-
GemStar infusion system - risk of over-infusion, low infusion rates or an interruption of infusion
(Hospira) Due to pump faults. (MDA/2013/016)
-
Gas pressurised spray devices for applying sprayable fibrin sealants used for intra-operative haemostasis
(Various manufacturers) risk of life-threatening/fatal gas or air embolism. (MDA/2013/015)
-
Oxoid antimicrobial susceptibility testing discs (AST) - presence of non-impregnated or ‘blank’ AST discs
(Finsbury Orthopaedics Ltd) Could lead to a false indication of antibiotic resistance. (MDA/2013/014)
-
Circadin 2mg prolonged-release tablets – error in patient information leaflet
(RAD Neurim Pharmaceuticals EEC Limited) Error in batches distributed since 11 February 2013. (EL (13)A/10)
-
Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing – sale suspended in Canada
(IND Diagnostics Inc, Canada; Alere International Ltd; Barrier Healthcare Ltd; E-Pharm Ltd) Due to concerns about the manufacturer’s quality systems. (MDA/2013/012)
-
Mitral Valve Repair System: MitraClip Clip Delivery System - risk of death or serious harm
(Finsbury Orthopaedics Ltd) Risk if the Actuator Knob of the Clip Delivery System (CDS) is turned in wrong direction. (MDA/2013/013)
-
ADEPT® 12/14 modular head hip components - higher than expected revision rate
(Finsbury Orthopaedics Ltd) Do not implant ADEPT® 12/14 modular head devices. (MDA/2013/010)
-
Cytarabine Injection 100mg/ml (1g/10ml) - potential for crystallisation
(Hospira UK Limited) Visually inspect vials for particulate matter prior to use and do not use if crystals are found - Class 4 medicines defect information (EL (13)A/09)
-
Montelukast 5 mg Chewable Tablets - error on the carton
(Mylan) Carton incorrectly states "For children 2 to 5 years" but patient information leaflet (PIL) correctly states "For children 6 to 14 years" – class 2 action within 48 hours. (EL (13)A/08)
-
Brochlor 1% w/w Eye Ointment – issue with seal integrity and compromised sterility assurance
(Sanofi-aventis) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/07)
-
GoldenEye 0.15% w/w eye ointment – issue with seal integrity and compromised sterility assurance
(Cambridge Healthcare Supplies Limited on behalf of Typharm Limited) Remaining stocks of the affected batches should be quarantined and returned to Cambridge Healthcare Supplies Limited – class 2 action within 48 hours. (EL (13)A/06)
-
Desloratadine ratiopharm 5mg film-coated tablets - higher than expected levels of impurities detected
(ratiopharm GmbH) Corrected batch numbers from EL (13)A/04 –class 3 action within 5 days. (EL (13)A/04 Rev 1)
-
Nasogastric feeding tubes - risk of incorrect placement
(Vygon Ltd) Due to incorrectly applied depth markings. (MDA/2013/009)
-
Isoline implantable cardioverter defibrillator (ICD) leads - risk of inappropriate shocking, pacing inhibition or shocking inhibition
(Hospira) Due to insulation abrasion. (MDA/2013/007)
-
Infusion pumps: Plum A+ and A+3 family of infusers - risk of interruption in therapy
(Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (MDA/2013/006)
-
Dexamfetamine Sulphate 5mg Tablets – packs may contain 3 blister strips instead of 2
(Auden Mckenzie Ltd) Small number may contain 3 blister strips –class 4 caution in use. (EL (13)A/05)
-
Laboratory analysers: ADVIA Centaur and ADVIA Centaur XP - failure of the wash interconnect circuit board
(Hospira) Failure to detect that the ‘Wash 1’ bottle is empty or incorrect indication that the ‘Wash 1’ bottle is empty. (MDA/2013/005)
-
Infusion pumps: Plum A+ single channel infuser systems - risk of interruption in therapy
(Hospira) Clinical staff failing to hear an audible alarm. (MDA/2013/004)
-
Gygel Contraceptive Jelly – test results did not comply with required specifaction
(Merck Sharp & Dohme Ltd) Being recalled as a precaution because results of assays for routine stability studies did not comply with required specification class 3 action within 5 days. (EL (13)A/03)
-
Ambulatory insulin infusion pumps - software problem
(Animas) From 1 January 2016 the pumps will not deliver insulin and will generate a call service alarm. (MDA/2013/003)
-
Tredaptive modified-release tablets - withdrawn throughout the European Union
(Merck Sharp & Dohme Ltd) Study showed failure to reduce major vascular events and increase in non-fatal serious adverse events – class 2 action within 48 hours. (EL (13)A/02)
-
Medical oxygen and medical air cylinders filled to 200 atmospheres - may cause damage to other devices
(Various manufacturers) Damage to devices such as anaesthetic machines, ventilators, incubators, respiratory support and resuscitation equipment. (MDA/2013/002)
-
External pacemaker: MICRO-PACE REF 4580 - temporarily withdrawn from sale
(Pace Medical and distributed in the UK by APC Cardiovascular) Potential for loss of ventricular output or sensing failure. (MDA/2013/001)
-
Vimpat 150mg Tablets - blister strips are incorrectly labelled
(OPD Laboratories Limited) Recall as some packs have incorrectly-labelled blister strips – class 2 action within 48 hours. (EL (13)A/01)
-
Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite - risk of misdiagnosis and treatment of vessels
(Vital Images) Due to incorrect calcium scores. (MDA/2012/081)
-
Typhim Vi - Orgaran 750 anti-Xa units solution for injection – incorrect patient information leaflet
(Merck Sharp & Dohme Limited trading as Organon Laboratories Limited) Technical portion of leaflet aimed at the healthcare professional omitted. (EL (12)A/35)
-
Samaritan public access defibrillator - risk of failure to deliver therapy
(HeartSine) may repeatedly turn on and off when not in use, switch off after delivering a single shock or give a premature low battery warning. (MDA/2012/079)
-
Batteries for HeartStart XL defibrillator/monitor - may shut down unexpectedly
(Various manufacturers) If defibrillator/monitor is not connected to the mains and is used with battery from affected batch it may shut down unexpectedly without providing low battery warning or audible alarm. (MDA/2012/077)
-
All medical devices and medicinal products containing chlorhexidine - Risk of anaphylactic reaction due to chlorhexidine allergy
(Various manufacturers) Check labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy. (MDA/2012/075)
-
AlboGraft polyester vascular graft - sales of AlboGraft now permitted in the UK
(Pace Medical and distributed in the UK by APC Cardiovascular) Grafts should be leak tested prior to use until end of December 2012. (MDA/2012/072)
-
External pacemaker - risk of under-sensing or output failure when used on patients with epicardial pacing wires
(Pace Medical and distributed in the UK by APC Cardiovascular) Do not use these pacemakers with epicardial pacing wires until they have undergone 3 upgrades. (MDA/2012/070)
-
Typhim Vi - Typhoid Polysaccharide Vaccine - antigen levels below required specification
(Sanofi Pasteur MSD) Some batches may have antigen levels below required specification – class 2 action within 38 hours. (EL (12)A/33)
-
ConchaTherm Neptune heated humidifiers - potential for failure of the speaker
(Various manufacturers) If speaker fails no alarm will sound in event of a device failure which could cause a delay in patient treatment. (MDA/2012/068)
-
Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml) - amended labels and patient information leaflet
(Pfizer Limited) Clarification of confusion resulting from amended labels and patient information leaflet – class 4 caution in use. (EL (12)A/31)
-
Surgical stapler Duet TRSTM Universal straight and articulating single use loading units (SULU) - potential to injure adjacent anatomical structures within the thorax and abdomen
(Covidien) may result in life-threatening post-operative complications. (MDA/2012/064)
-
Silicone tracheostomy tubes - eyelets of silicone tracheostomy tubes damaged by holder
(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
-
Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical (MDA/2012/061)
This Medical Device Alert has been issued as there is a risk of inappropriate shock or therapy failure due to wear of lead insulation when using implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.
-
Epistatus, Midazolam 10mg in 1ml Buccal Liquid x 5ml - packs containing new syringes to be distributed
(Special Products Ltd) Packs containing the new syringe to be distributed from September 2012 – class 4 caution in use - class 4 caution in use. (EL (12)A/26)
-
Animas ambulatory insulin infusion pumps - risk of compromised insulin therapy due to failure of the buttons
(EMS Medical) Deterioration has led to the coating tearing and the edge of the keypad peeling away from the pump. (MDA/2012/059)
-
Zovirax Suspension 200mg/5ml - incorrect dosing instructions
GlaxoSmithKline UK are recalling multiple batches of 125ml bottles of the above product.
-
Powered wheelchairs - drive wheel may detach from the wheelchair
(Invacare) Technicians should be advised of the revised removal/refitting procedure. (MDA/2012/060)
-
Paracetamol Tablets 500mg - incorrect blister foil
(Actavis UK Ltd) Use of incorrect blister foil which fails to meet the specification for child resistancen – class 2 action within 48 hours. (EL (12)A/24)
-
Neonatal and paediatric endotracheal tube clamp/holder - risk of airway loss due to slippage or airway obstruction
(EMS Medical) Identify, do not use and dispose of affected devices. (MDA/2012/049)
-
Tianjie Dental Falcon portable X-ray unit and other non CE-marked dental X-ray units - lacks sufficient shielding in the X-ray tube
Identify and stop using this and similar non CE-marked devices. (MDA/2012/046)
-
Legendair and Supportair Portable Ventilators - potential for the ventilator’s internal battery to fail
(Airox) Can result in non-ventilation of the patient. (MDA/2012/044)
-
Schiller electrodes: Silver packet - premature drying up of electrodes
(Nessler Medizintechnik) May prevent shock delivery and cause failure to defibrillate and a reduced chance of survival for the patient. (MDA/2012/043)
-
FRED easy Defibrillators - false defibrillator error message
(Nessler Medizintechnik) May prevent shock delivery and cause failure to defibrillate and a reduced chance of survival for the patient. (MDA/2012/042)
-
Mobile patient hoist carabiners - can unexpectedly break and detach from the spreader bar
(Invacare) Excessive wear of these aluminium carabiners can result in a patient falling from the hoist. (MDA/2012/038)
-
Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) – failure to appropriately decontaminate
(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
-
Metal-on-metal (MoM) hip replacements - updated advice with patient follow ups
(All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)
-
RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes) - light may fail during intubation
(M.A.
-
Anaesthetic machines and associated devices - reports about what check failures cause
(All manufacturers) reports say that failure to check anaesthetic machines and or the breathing system is a major factor in many anaesthetic misadventures, including some that have resulted in hypoxic brain damage or death.(MDA/2012/031)
-
Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe
(Lincoln Medical Limited) Potential problem could result in a failure to deliver any adrenaline at all in an emergency situation – class 2 action within 48 hours. (EL (12)A/20)
-
Neonatal endotracheal tube SCP clamp/holder - risk of airway loss
(Capatex Medical) slippage or obstruction of the airway as a result of an over-tightening of the clamp/holder causes risk of airway loss. (MDA/2012/029)
-
Levothyroxine 100mcg tablets - recall of Teva UK and Numark branded product
(Teva UK and Numark liveries) Remaining stock should be returned to wholesaler for credit – class 3 action within 5 days. (EL (12)A/13)
-
Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation - diagnosis of breast cancer difficult in some cases
(Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult. (MDA/2012/022)
-
Left ventricular cardiac resynchronization therapy (CRT) leads - risk of worsening symptoms of heart failure
(St Jude Medical) wear and/or abrasion of lead insulation after implantation causes risk of worsening symptoms of heart failure. (MDA/2012/021)
-
Oral swabs with a foam head - heads may detach during use
(All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)
-
Rabipur - potential problem packaging of syringes
(Novartis Vaccines and Diagnostics GmbH) Potential problem with packaging of the syringes supplied with specific batches of Rabipur – class 4 caution in use. (EL (12)A/13)
-
Implantable cardioverter defibrillators (ICD) - risk of loss/ pacing therapy
(Medtronic) once elective replacement indicator (ERI) is reached there is a risk of loss of ICD/pacing therapy from rapid battery depletion that occurs around 2.5 years after implantation. (MDA/2012/014)
-
Silicone gel filled breast implants - updated information on filler
(Poly Implant Prothese (PIP) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (MDA/2012/011)
-
Level 1® Normothermic IV fluid administration sets (specific models) - risk of fluid / blood loss or delay in therapy
(Smiths Medical) increase in reports of disconnections of the Luer lock connector for model numbers D-60 HL and DI-60HL at the patient end of the tubing for these fluid warming sets, which can lead to a risk of fluid/ blood loss or delay in therapy. (MDA/2012/009)
-
Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) - do not use for adult or paediatric thoracic surgery procedures
(Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.(MDA/2012/005)
-
Vigantoletten (1000 IU Colecalciferol) Tablets – reminder that tablets contain soya oil
(Merck Serono) Contraindicated for patients with allergies to soya oil - class 4 caution in use. (EL (14)A/15)
-
Dekristol (20,000 IU Colecalciferol) Capsules - contain arachis (peanut) oil
(MIBE GMBH) Contraindicated for patients with allergies to peanut oil - calls 5 caution in use. (EL (12)A/03)
-
Bivona® Neonatal Pediatric and Flextend tracheostomy tubes - risk of dislodge of tube
(Smiths Medical) it may be difficult to remove incorrectly connected accessories and they may need excessive force to disconnect, which can cause a dislodge of the tube that needs to be changed. (MDA/2012/002)
-
Clopixol Conc Injection (500mg/ml) - cracked ampoules
(Lundbeck Limited) Reports of cracked ampoules and concerns about guaranteeing sterility – class 2 actions within 48 hours (EL (11)A/33)
-
Auxiliary common gas outlet (ACGO) for anaesthetic machine - no fresh gas flow to patient with wrong setting
(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)
-
Xigris 5 mg and 20 mg recall due to risk/benefit concerns
(Eli Lilly) Recall following clinical trial findings showing lack of efficacy and risk/benefit concerns – class 1 action now. (EL (14)A/15)
-
Some EnRhythm® and EnRhythm MRI™ implantable pacemakers - software update may trigger unexpected ERI
(Medtronic) a software update of the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI. (MDA/2011/097)
-
Reusable laryngoscope handles - inquest found contaminated device caused patient's death
(All models and manufacturers) MHRA received a report of an inquest that found a patient died after a laryngoscope handle had not been decontaminated appropriately between each patient use. (MDA/2011/096)
-
Nurofen Plus tablets containing rogue blister strips in additional 2 cartons
(Reckitt Benckiser (UK) Ltd) Recall of all unexpired stock of Nurofen Plus tablets in any pack size – class 1 action now. (EL(11)A/21)
-
Eleganza standard and deluxe beds - reminder to follow up on field safety notice
(Linet) manufacturer has not received sufficient confirmation of actions from users after it issued a field safety notice on some models of bedframes made before December 2005 that may have cracks. (MDA/2011/092)
-
Implantable pulse generators (IPGs) neurostimulators - confirm actions from field safety notice
(St Jude Medical) manufacturer not received sufficient confirmation of action after a field safety notice was sent out on the faulty battery components that could result loss in ability to communicate with the programmer or recharge in some IPGs. (MDA/2011/079)
-
Headrest attachment to operating tables - confirm actions after receipt of field safety notice
(Maquet Ltd) manufacturer has not received sufficient confirmation of actions after it sent a field safety notice on safe use of connection fixture 1002.65A0 and 1002.65S0. (MDA/2011/075)
-
Implantable cardioverter defibrillator (ICD) - risks with pacing inhibition
(Sorin CRM) pacing inhibition causes risk of bradycardia / syncope; also potential association between pacing inhibition and ventricular oversensing if 'PhD' is 'on' and the device is connected to high polarisation defibrillation leads. (MDA/2011/073)
-
Canesten Pessary - 2 batches have wrong patient information leaflet
(Bayer Consumer Care Division) Two batches inadvertently placed on the market containing patient information leaflet (PIL) for prescription only medicine (POM) product - class 4 caution in use. (EL(11)A/17)
-
Needle-free intravenous connectors - incompatibility and risk of infection
(All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/2011/068)
-
SQ-RX® pulse generator, model 1010 - subcutaneous implantable cardioverter defibrillator (S-ICD) - battery might die early
(Cameron Health) risk of premature depletion of battery before the 3 nominal months. (MDA/2011/067)
-
Plum A+ infusion pumps - potential failure
(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
-
Dual Chamber Pacemakers - confirm actions with manufacturer after receipt of field safety notices
(Medtronic Ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (Reference: FA507). (MDA/2011/060)
-
Pacemaker - Reply and Esprit models interrogated with programmer containing software version 2.24 - software anomaly
(Sorin CRM) field safety notice published after a programmer software anomaly was found that could lead to cardiac instability or unnecessary explant due to inconsistent battery information. (MDA/2011/056)
-
Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - risk of inappropriate shocks
(Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)
-
Ligasure blunt tip laparoscopic sealer/divider - potential risk of serious thermal burns
(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)
-
All types, makes and models of breast implants - potential increased risk of anaplastic large cell lymphoma (ALCL)
(All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK. (MDA/2011/017)
-
Peristeen Anal Irrigation System - reports of bowel perforation (rare)
(Coloplast Limited) incidents of bowel perforation after a rectal catheter is inserted as part of the anal irrigation system. (MDA/2011/002)
-
Umbilical cord clamps - close the clamp by squeezing it at the grips until you hear a click
(All) incorrect placement of the clamp on the umbilical cord has lead to improper seal and blood loss in a small number of cases, which can be fatal. (MDA/2010/094)
-
All Oxylog 3000 emergency/transport ventilators - risk of gas being re-breathed
(Draeger) reports of device that gave insufficient ventilation to small children, which could result in gas being re-breathed and a potential dangerous rise in CO2. (MDA/2010/092)
-
Recall of Avandia 4mg, 8mg, Avandamet 1mg/500mg, 2mg/500mg, 2mg/1000mg, 4mg/1000mg
(GlaxoSmithKline (GSK)) Recall of all undispensed UK packs purchased through approved suppliers Alliance Healthcare and AAH Pharmaceuticals - class 3 action within 5 days. (EL(10)A/22)
-
Silicone gel filled breast implants - advice on clinical management of women with implants
(Poly Implant Prothese (PIP)) advice for implanting surgeons to identify women with PIP implants and advise them that further testing will be carried out. (MDA/2010/078)
-
SleepStyle CPAP devices - risk of therapy stoppage
(Fisher & Paykel Healthcare) deterioration of power cords for specific models may cause therapy to stop. (MDA/2010/076)
-
Intravenous (IV) extension sets with multiple ports - risk of backtracking
(All brands) risk of back-tracking when an IV line has multiple access ports, which can lead to under-infusion or bolus delivery of IV drugs. (MDA/2010/073)
-
Medical device alerts: vascular catheters - invalid CE marking
(Kimal) CE marking for these specific vascular catheters is invalid; safety and performance of devices have not been submitted for independent assessment. (MDA/2010/072)
-
LIFEPAK 20/20e defibrillator/monitor - component failures
(Medtronic/Physio-Control) component failures affect AC (mains) and/or DC (battery) operating power, which may lead to the defibrillator not able to deliver therapy. (MDA/2010/070)
-
Novabel® dermal filler - practitioners should stop use and return all unused products
(Merz Pharmaceuticals GmbH) manufacturer has received reports of adverse reactions to the filler. (MDA/2010/064)
-
Anaesthetic vaporisers - failure to attach vaporisers to the anaesthetic machine causes gas leakage according to reports
(All manufacturers) reports received: failure to correctly attach vaporisers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness. (MDA/2010/052)
-
Fetal monitor/cardiotocograph (CTG) - adverse outcomes still reported
(All) adverse outcomes are still reported when CTG traces appear normal - this replaces alert SN 2002(23) issued August 2002. (MDA/2010/054)
-
Implantable vagus nerve stimulators (VNS) - follow manufacturer's latest field safety notices
(Cyberonics VNS Therapy) device can have premature battery depletion (models 103 and 104), inaccurate battery life projection (models 103, 104 and 250), loss of therapy (all models) and painful, erratic or atypical stimulation (all models). (MDA/2010/050)
-
All chest drains when used with high-flow, wall mounted low-vacuum suction systems - patient reports pneumothorax
(All) report that a direct connection caused a patient under active suction to sustain a tension pneumothorax. (MDA/2010/040)
-
Aquarius haemofiltration machines - follow instructions carefully
(Edwards Lifesciences Ltd, supplied by Baxter Healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy. (MDA/2010/039)
-
All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators - inadequate ventilation
(All) harm of inadequate patient ventilation and oxygenation could have been avoided if an alternative means of ventilation had been used earlier. (MDA/2010/036)
-
All models and lot numbers of silicone gel filled breast implants - unapproved composition of silicone gel
(Poly Implant Prothese (PIP)) French medical device regulatory authority (AFSSAPS) found the composition of silicone gel for most breast implants have been different to the one approved since 2001 (MDA/2010/025)
-
Intracranial stent - don't use to treat intracranial aneurysms without embolisation coils
(Balt Extrusion) potential for patient death if you use any SILK artery reconstruction device to treat intracranial aneurysms without embolisation coils. (MDA/2010/023)
-
Hansen-type coloured dialysis fluid line connectors - incorrectly configured
(All manufacturers) potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) which results in significantly less efficient dialysis. (MDA/2010/020)
-
Anaesthetic gas scavenging systems (AGSS) - excessive pressure in anaesthetic breathing systems can cause serious harm
(all manufacturers) excessive pressure in anaesthetic breathing systems caused by blockage of AGSS hoses can cause serious harm to patient. (MDA/2010/021)
-
Teligen and Cognis defibrillators - risks for devices implanted subpectorally
(Boston Scientific) specific models of defibrillators implanted subpectorally have a risk of loss of shock therapy, inappropriate shock therapy, loss of pacing therapy or loss of anti-tachycardia pacing. (MDA/2010/012)
-
Intraocular lens (IOL) - hydrophilic acrylic - opacification
(intraocular lens (IOL) - hydrophilic acrylic) opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase. (MDA/2010/008)
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Devices used for endometrial ablation - clinicians should confirm patients have no evidence of uterine perforation or false passage
(All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices. (MDA/2010/006).
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All types of bed mattresses - contamination through damaged mattresses or covers
(All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used. (MDA/2010/002)
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Medical devices in general and non-medical products - reminder of risks
(General) Users should avoid (if possible), off-label use of medical devices, the modification of medical devices and the use of non CE-marked medical devices in clinical settings. (MDA/2010/001)
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Ultrasound transducer - review advice by the Advisory Committee on Dangerous Pathogens (ACDP)
(All manufacturers) Potential onward transmission of abnormal prion protein when ultrasound transducer probes with internal lumen during transrectal prostate biopsies on men at risk of vCJD. (MDA/2009/080)
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Aquarius haemofiltration machine - manufacturer has updated their actions for software problems
(Edwards Lifesciences Ltd) the manufacturer has updated their corrective actions for software problems with haemofiltration machines. (MDA/2009/076)
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Tec 6 Plus Desflurane vaporiser - age-related failure of internal component is higher than expected
(GE Healthcare) age-related failure of internal component causes either too much or too little delivery of anesthetic agent to patients. (MDA/2009/072)
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Stopcocks and specific products that contain non-lipid resistant stopcocks - risk of leakage or air embolism
(Arrow®) risk of leakage or air embolism due to crack in hub at the female Luer connector during delivery of infusions that contain lipids. (MDA/2009/047)
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Kappa 600/700/900 series and Sigma 100/200/300 series pacemakers - potential unexpected failure
(Medtronic Ltd) certain Kappa® and Sigma® series pacemakers may suddenly fail, which may cause bradycardia symptoms (fainting or light headedness) or serious injury/death in patients dependent on a pacemaker.(MDA/2009/038)
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Bioprosthetic heart valves - follow manufacturer's instructions to prepare implants before use
(All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation. (MDA/2009/032)
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Goldmann applanation tonometer prism - use recommended disinfectants
(Haag-Streit Ag) inappropriate disinfectants may cause damage the tonometer prism, which could result in corneal irritation. (MDA/2009/028)
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Zenith abdominal aortic aneurysm (AAA) endovascular grafts and associated H&L-B One-Shot - serious injury or death of the patient during graft deployment
(Cook Medical Incorporated) potential for serious injury or death of the patient due to the difficulty or inability to release the suprarenal stent during graft deployment. (MDA/2009/023).
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Servo ventilators 300 and 300A with automode function - risk of poor ventilation
(Maquet Critical Care AB) risk of inadequate ventilation of neonatal or paediatric patients without giving warning by any alarm. (MDA/2009/020)
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UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - identify affected devices and remove from service immediately
(MECALL Srl) an X-ray tube head has fallen onto the table after the support cable and the backup ‘safety device’ failed at the same time. (MDA/2009/014)
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SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps - scan patients with these
(Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. (MDA/2008/087)
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Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs - wheelchairs should not be transported in vehicles until tie-down brackets are updated
(Invacare) Original tie-down brackets fitted to these wheelchairs are not suitable for the new heavy duty 4-point webbing tie-down systems manufactured by Unwin Safety Systems Limited. (MDA/2008/077)
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Implantable cardioverter defibrillators (ICDs) - disable all high voltage shock therapies before you remove ICD
(All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)
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Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts or total knee replacement implants - do not implant affected devices
(Stryker UK Ltd) Manufacturing defect means there is a risk of loosening, excessive wear and fracture of knee replacement components, (MDA/2008/066).
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MDA/2008/065 - Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders
This Medical Device Alert highlights an error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status.
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N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders neurostimulator programmers - error in programmer software
(Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)
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Puma and Beatle battery powered wheelchairs - trace these devices and advise users about how to use them in vehicles
(Movingpeople.net or Handicare) Some variants of the Puma and Beatle are too heavy for the standard 4-point webbing tie-down system. (MDA/2008/052)
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Lancing devices (used in pharmacy settings) - risk of transmission of blood borne infections
(All brands) there is a risk of transmission of blood borne infections if a lancing device is used for testing between multiple patients contrary to the manufacturer's instructions for use. (MDA/2008/046)
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Implantable drug pumps for intrathecal therapy - risk of temporary or permanent neurological impairment
(All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. (MDA/2008/038)
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Posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs - ensure you follow manufacturer's instructions to check these are fitted, adjusted, used, cleaned and correctly maintained
(All) inappropriate type of or incorrectly fitted or adjusted posture/safety belt can lead to death or serious injury of the occupant. (MDA/2008/037)
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Needle-free intravascular connectors - risk of infection
(All brands) reports of the top/septum staying in a recessed position after use; swabbing of the connector in this condition may lead to inadequate decontamination. (MDA/2008/016)
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Hard-shell venous reservoirs and oxygenators used during heart surgery - ensure you check vent ports and that the oxygen supply is functioning before use
(Various manufacturers) a bolus of air was forced up the venous line to the heart when quick-prime line was misconnected to the vent port of a hard-shell venous reservoir; also a vaporiser prevented the oxygen supply reaching the oxygenator for cardiopulmonary bypass during surgery. (MDA/2008/005)
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VKS, RT-Plus and TC-Plus femoral and tibial knee components for total knee replacement implants (specific lot numbers) - recall has been extended
(Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd) recall extended for these implants, which may have the incorrect composition of alloy. (MDA/2008/003)
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Kimba Spring paediatric buggies - trace buggies supplied from April 2003 to April 2007 to inspect frame
(Otto Bock) reports of problems with frame that can lead to insecure seating system allowing it to fully tilt forwards or backwards without warning. (MDA/2007/096)
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Medical device alert: external temporary cardiac pacemaker (bedside model 4170 serial numbers 1 - 998) - return these to manufacturer and ensure rapid pace switch is off before you shut the device down
(APC Medical Ltd) the manufacturer has found potential for rapid pacing while switching off this temporary pacemaker. (MDA/2007/095)
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VKS, RT-Plus and TC-Plus femoral and tibial knee components of total knee replacement implants - do not implant affected products
(Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd) some products have been made from an an incorrect alloy composition due to a manufacturing error. (MDA/2007/092)
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Injectable polymeric cements used in vertebroplasty, kyphoplasty and pedicle screw augmentation - updated recommendations for use
(All) MHRA has issued updated advice on bone cements used in percutaneous vertebroplasty and balloon kyphoplasty procedures. (MDA/2007/088)
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Automatic external defibrillator Welch Allyn batch AED 20 - recall
(Welch Allyn) recall of defibrillators to correct a malfunction that prevents or delays the delivery of therapy, which can lead to failure to resuscitate a patient. (MDA/2007/085)
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Locking nuts in Colorado II spinal implant system - recall
(Medtronic) recall of certain lots of Colorado II locking nuts due to a manufacturing defect. (MDA/2007/084)
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DePuy SmartSeal™ pressurisers - orthopaedic bone cement restrictor instrumentation - femoral and acetabular pressurisers (5 pack) - recall
(DePuy CMW) recall of SmartSeal™ pressurisers used during cemented total hip joint replacement surgery as outer peelable pouch seals may be creased and may not be intact. (MDA/2007/081)
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Medical device alert: Sprint Fidelis implantable cardioverter defibrillator (ICD) lead - reports of lead conductor fracture
(Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality. (MDA/2007/078)
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Bioresorbable screw: CALAXO interference screw implants - recall
(Smith & Nephew Inc.) recall of all lot numbers and item codes of CALAXO screws which were first distributed in the UK in 2006. (MDA/2007/076)
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Hip implants for hemiarthroplasty - Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses - packaging could affect sterility
(Biomet) recall of certain endoprostheses as the sterile barrier packaging has become brittle with age, which could compromise product sterility. (MDA/2007/068)
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Hip resurfacing implants - adept acetabular cups - some labelled incorrectly
(Finsbury Orthopaedics) some acetabular cups have been labelled with the wrong cup diameter. (MDA/2007/067)
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Birmingham Hip Resurfacing (BHR) hip resurfacing implants acetabular cups - may need to be revised early
(Smith & Nephew Orthopaedics Ltd) inappropriate mixing of head and cup sizes due to incorrect labelling of may require early revision due to loose joint fit. (MDA/2007/063)
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Hospital beds - full decontamination details not included
(Hill-Rom TotalCare Duo 2) manufacturer does not include full decontamination details with the instructions for use. (MDA/2007/065)
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Scanbed 750 (SB 750) with integral bed rails - profiling bed - literature updated
(Invacare Ltd) manufacturer has updated the pre-sales literature due to risk of asphyxiation to children from potential entrapment between the wooden bed rails. (MDA/2007/056)
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DePuy Ultima TPS femoral stemtotal used in combination with Ultima metal-on-metal articulation hip replacement - unexplained groin pain
(DePuy International Ltd) need for early revision due to periprosthetic soft tissue necrosis. (MDA/2007/054)
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Needle-free intravascular connectors - check updated instructions
(All brands) instructions for several brands of these devices have changed significantly in the last 2 years. (MDA/2007/051)
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Optima XL stubby handle and laryngoscope handle - delays to intubation
(Timesco of London Ltd.) possibility that poor contact between Timesco stubby handles and Timesco laryngoscope blades (models: 3000.308.10 and 3000.308.10T) may result in the bulb not being lit with subsequent delays to intubation. (MDA/2007/045)
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Primus anaesthetic workstation - ensure the backup oxygen cylinder’s non-interchangeable screw threaded (NIST) fitting is connected to the appropriate oxygen inlet
(Draeger Medical UK Ltd) report of an incorrect connection of the backup oxygen cylinder, which would prevent backup oxygen supply if the oxygen pipeline failed. (MDA/2007/040)
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External pacemakers and temporary cardiac pacing leads - concerns that insecure systems still being used
(All ) concerns that some insecure adaptor systems are being used to connect temporary pacing leads to external pacemakers. (MDA/2007/042)
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Flexible endoscopes - avoid placing device in storage and drying cabinets where ultraviolet light shines on them
(Olympus) outer sheath and light guide tube of endoscopes may be damaged if directly exposed to ultraviolet (UV) light used in some endoscope storage and drying cabinets. (MDA/2007/034)
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Endoscope storage and drying cabinets - check all flexible endoscopes stored in these facilities for damage
(AFOS (NSE)) the outer sheath and light guide tube of flexible endoscopes may be damaged by prolonged exposure to ultraviolet (UV) light used in these endoscope storage and drying cabinets. (MDA/2007/035)
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Patient hoists and slings - ensure you follow manufacturer's instructions for use and that you carry out risk assessments
(All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. (MDA/2007/031)
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Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families - identify patients with these implants
(Boston Scientific Ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected. (MDA/2007/023)
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Lucas external cardiac compressor - ensure users are aware of update to ventilation in instructions
(Jolife AB) instructions for use have been updated after reports of inadequate ventilation in non-intubated patients, thoracic cage and lung damage and raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply. (MDA/2007/013)
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Beds rails and grab handles - incorrect use can cause death
(All) bed rails can successfully prevent falls, but if used incorrectly they can result in deaths of bed occupants by asphyxiation due to entrapment. (MDA/2007/009)
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Lancing devices used in nursing homes and care homes - correction to list of disposable single-use lancing devices
(All) MHRA continues to receive reports of hepatitis B outbreaks in nursing homes and care homes, which is linked with single-use lancing devices being used on multiple patients. (MDA/2006/066)
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Medical pacemakers (Identity SR model 5172, Identity DR model 5370 and Identity XL DR model 5376) - perform a manual measured data reading in follow-ups
(St Jude Medical UK Ltd) a programmer software anomaly can occur when these devices are used together, which can cause inaccurate display of battery voltage, battery longevity and elective replacement indicator (ERI) status. (MDA/2006/065)
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Hand pieces used with oral / maxillofacial surgery drills - ensure maintenance procedures are in place to prevent drill from overheating
(General) significant increase in the number of reports from patients receiving oral burns from hand pieces used with overheated drills mostly due to lack of appropriate maintenance. (MDA/2006/055)
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Sedana Medical AnaConDa anaesthetic conserving device - ensure procedures are in place for use of device with most up to date instructions
(Anmedic UK); adverse incident reported on risk of anaesthetic overdose due to inconsistencies in the instructions for use. (MDA/2006/045)
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Implantable pacemaker and implantable defibrillator families (INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR2, VENTAK PRIZM 2 VITALITY, VITALITY 2) - recall
(Guidant) recall of subset of implantable pacemakers and defibrillators due to component failure that may lead to malfunction or premature depletion of battery. (MDA/2006/038)
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Electrically powered indoor wheelchairs (EPICs) - inform users of limitations
(All) EPICs are being used outdoors and or as seats in vehicles when they are designed specifically for indoor use, which causes a risk of serious injury. (MDA/2006/036)
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MiniCap peritoneal dialysis disconnect cap with povidone-iodine - monitor thyroid function in patients with small fill volumes
(Baxter Healthcare Ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (MDA/2006/022)
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All cochlear implants - update on immunisation recommendations
(All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)
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Sigma® implantable pacemakers - advise patients to contact their follow-up clinic immediately if they experience a return of symptoms
(Medtronic) failure of interconnecting wires may cause loss of pacing output from atrial and or ventricular ports, premature depletion of battery, intermittent or total loss of telemetry, undersensing, high lead impedance values, loss of rate response, device reset to manufacturer's default settings. (MDA/2005/072)
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INSIGNIA and NEXUS implantable pacemakers - recall
(Guidant) component failure. (MDA/2005/070)
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INSIGNIA and NEXUS implantable pacemakers - consider replacement of elective device if there are one or more malfunctions
(Guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI), and/or reset warning message upon interrogation. (MDA/2005/067)
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Lancing devices - you should not use single patient lancing devices for multiple patients
(Various including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix and some others) use of these devices to take blood samples for multiple patients has implications in the transmission of hepatitis B between patients. (MDA/2005/063)
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Implantable cardioverter defibrillators (ICDs) - ensure you have updated software for models 3510 and 3510+ ICD programmers
(St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)
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Styrene polymer based surgical and examination gloves - ensure these do not come into contact with solvents
(Various manufacturers) some synthetic gloves degrade and may disintegrate when in contact with certain solvents such as acetone contained in spray-on wound dressings. (MDA/2005/043)
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Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) - recall
(Guidant) failure of component results in potential loss of cardioversion, defibrillation and reduced longevity of device.(MDA/2005/041)
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VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) - ensure follow ups are within every 3 months
(Guidant) potential loss of cardioversion, defibrillation or pacing therapy of model 1861 due to diversion of high voltage shock. (MDA/2005/037)
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CONTAK RENEWAL® (model H135) and CONTAK RENEWAL® 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds) - follow up with patients within every 3 months
(Guidant) potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock. (MDA/2005/038)
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Biokit Best 2000 laboratory analyser used with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay; only use if combination has been validated
(Biokit Ltd.); this combination of assay and laboratory analyser may result in observation of false results when in use and has not been validated by manufacturer; (MDA/2005/036).
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Batch 01A1 of Prosan Flexi-T 300 intrauterine devices - ensure you read all guidance from manufacturer and you have access to small clamps
(Prosan International B.V) detachment of control threads on attempt to remove device. (MDA/2005/021)
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Heat patches or heat packs intended for pain relief - follow manufacturer's instructions and report any adverse reactions
(All) risk of burns. (MDA/2005/027)
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Trilucent (soya bean oil filled) breast implants - update on actions from previous risks
(Lipomatrix Inc) conclusions of research after device was recalled for risks of break down of filler and update of HN2000(05). (MDA/2004/047)
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Implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx - identify affected patients
(Medtronic) extended charge times and inability to deliver therapy for a subset of the above devices when battery voltages are close to elective replacement indicator (ERI). (MDA/2004/045)
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Cidex® ortho-phthalaldehyde (OPA) high level disinfectant solution - carry out risk assessment before use if there is no alternative
(Johnson & Johnson) repeated exposure to device after it was used to manually reprocess urological instruments may have caused hypersensitivity in some patients with a history of bladder cancer, undergoing repeated cystoscopy. (MDA/2004/022)
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Implantable defibrillators - follow up with patients given these devices
(Medtronic) Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277; potential battery defect; possible rapid depletion. (MDA/2004/019)
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Medical device alert; ABG I uncemented acetabular cups for total hip replacement - identify all patients who have received this device
(Benoist Girard) possibility for cup to wear, cause asymptomatic acetabular osteolysis and loosen in severe cases.(MDA/2004/011)
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Transilluminators used with neonates - ensure you follow the instructions and that the device can be used with neonates
(All) use of an inappropriate light source for transillumination can result in burns. (MDA/2003/044)
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Electrosurgical (diathermy) accessories - ensure procedures are in place to check all electrosurgical accessories regularly
(All) malfunction and failure during use. (MDA/2003/037)
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SynchroMed® implantable drug pump - consider changing diamorphine for another medicine
(Medtronic) diamorphine solution is incompatible with the implantable drug pump. (MDA/2003/035)
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Medical device alert: expanding haemostatic agents and expanding tissue sealant - read instructions
(All) expanding haemostatic agents or expanding tissue sealants have risk of blockage or compression. (MDA/2003/018)
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External pacemakers - sudden increase in pacing rate and change of mode
(APC Medical Ltd) the pacing rate for models E4162, E4164, E4165 and E4166 may increase by 20 pulses per minute and change in pacing mode in some cases. (MDA/2003/008)
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