Medical device alerts archived in May 2015

A list of all medical device alerts that were archived in May 2015.

We’ve reviewed all our medical device alerts and have decided to archive the ones listed below.

Reference Title
MDA/2003/018 Expanding Haemostatic Agents and Expanding Tissue Sealants.
MDA/2004/011 ABG I Uncemented Acetabular Cups for Total Hip Replacement
MDA/2004/022 Cidex® OPA ortho-phthalaldehyde high level disinfectant solution.
MDA/2005/021 Prosan Flexi-T 300 intrauterine devices - batch 01A1.
MDA/2005/027 Heat patches or heat packs intended for pain relief.
MDA/2005/036 Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay.
MDA/2005/041 Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)
MDA/2005/043 Styrene polymer based surgical and examination gloves – various manufacturers.
MDA/2005/061 Footswitches for use with all models of ConMed or Valleylab electrosurgical units (ESUs), including footswitches manufactured by third parties.
MDA/2005/063 Lancing Devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices
MDA/2006/036 Electrically Powered Indoor Wheelchairs (EPICs).
MDA/2006/045 Anaesthetic conserving device: Sedana Medical AnaConDa
MDA/2007/013 Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd.
MDA/2007/035 Endoscope storage and drying cabinets: all endoscope storage facilities (ESF) manufactured by AFOS (NSE) Ltd.
MDA/2007/051 All brands of needle-free intravascular connectors.
MDA/2007/054 Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation.
MDA/2007/056 Profiling bed: Invacare Scanbed 750, (SB 750) with integral bed rails.
MDA/2007/063 Hip resurfacing implants.  Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd. (see Appendix for affected lot numbers).
MDA/2007/065 Hospital beds: Hill-Rom TotalCare Duo 2.
MDA/2007/067 Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes).
MDA/2007/068 Hip implants for hemiarthroplasty – Austin-Moore, F.R. Thompson  and Thompson Modular endoprostheses manufactured by Biomet UK Ltd.
MDA/2007/076 Bioresorbable Screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc.  All lot numbers and all item codes distributed since 2006.
MDA/2007/081 Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW.
MDA/2007/084 Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system.  Catalogue number 8634111. 
MDA/2007/085 Automatic external defibrillator - Welch Allyn AED 20.
MDA/2007/088 Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation.
MDA/2007/092 Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers).
MDA/2007/096 Kimba Spring paediatric buggies manufactured by Otto Bock.
MDA/2008/003 Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew orthopaedics Ltd (specific lot numbers).
MDA/2008/005 Hard-shell venous reservoirs and oxygenators used for cardiopulmonary bypass during heart surgery: various manufacturers.
MDA/2008/016 Needle-free intravascular connectors.  All brands.
MDA/2008/037 All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs.
MDA/2008/052 Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare.
MDA/2008/065 Neurostimulator programmers manufactured by Medtronic – N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders.
MDA/2008/066 Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix).
MDA/2008/077 Storm3, Storm TT, Typhoon and Typhoon II battery powered wheelchairs manufactured by Invacare.
MDA/2009/020 All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens).
MDA/2009/047 Stopcocks (catalogue numbers. W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by ARROW®.
MDA/2009/072 Tec 6 Plus Desflurane vaporiser manufactured by GE Healthcare (formerly Datex-Ohmeda). Also distributed by Baxter Healthcare.
MDA/2010/021 Anaesthetic gas scavenging systems (AGSS).  All manufacturers.
MDA/2010/040 All chest drains when used with high-flow, low-vacuum suction systems (wall mounted).
MDA/2010/072 Vascular catheters: K-Flow Access Catheters.  Kimal High Flow (HF) Haemodialysis Catheters.  Kimal Right Atrial (KRA) Catheters. Manufactured by Kimal. Devices with specific product codes and expiry dates are affected.
MDA/2010/076 SleepStyle CPAP devices.  Manufactured by Fisher & Paykel Healthcare.  Specific model and lot numbers are affected.
MDA/2010/092 All Oxylog 3000 emergency/transport ventilators. Manufactured by Draeger.
MDA/2011/002 Peristeen Anal Irrigation System manufactured by Coloplast Limited.
MDA/2011/092 Eleganza Standard (model prefix 1GS) and Deluxe (model prefix 1GL) beds manufactured by Linet prior to December 2005.
MDA/2012/002 Tracheostomy tubes: Bivona®  Neonatal, Pediatric and Flextend.Manufactured by Smiths Medical.Lot numbers from 1631477 to 1923406 inclusive.
MDA/2012/005 Stapler. Duet TRSTM universal straight and articulating single use loading units (SULU) Manufactured by Covidien.
MDA/2012/019 Risk of life-threatening or fatal embolism during, or immediately after, application of fibrin sealants using air- or gas-pressurised spray devices.
MDA/2012/029 Neonatal endotracheal tube SCP clamp/holder manufactured by Capatex Medical
MDA/2012/032 RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes)
MDA/2012/038 Mobile patient hoist carabiners manufactured by Invacare
MDA/2012/042 FRED easy Defibrillators manufactured by Schiller
MDA/2012/043 Schiller electrodes: Silver packet, manufactured by Nessler Medizintechnik
MDA/2012/044 Legendair and Supportair Portable Ventilators manufactured by Airox
MDA/2012/049 Neonatal and paediatric endotracheal tube clamp/holder manufactured by EMS Medical
MDA/2012/057 Sterile Water for Irrigation 1000ml. Manufactured by Baxter Healthcare Ltd. Product code: UKF7114. Lot no: 12D10B26
MDA/2012/059 Animas ambulatory insulin infusion pumps. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management system Animas® Vibe
MDA/2012/060 Powered wheelchairs.  All chairs in the Harrier range.  Manufactured by Invacare.
MDA/2012/064 Surgical stapler. Duet TRSTM Universal straight and articulating single use loading units (SULU).
MDA/2012/068 ConchaTherm Neptune heated humidifiers.  Manufactured by Teleflex.  Product codes: 425–00, 425–10 and 425–30.  Specific serial numbers.
MDA/2012/077 Defibrillators, Non Implantable Battery
MDA/2012/081 Workstation software for computed tomography systems: Vitrea fX, Vitrea and Vitrea Enterprise Suite.  Manufactured by Vital Images. 
MDA/2013/005 Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific assays.  ADVIA Centaur® and ADVIA Centaur® XP, manufactured by Siemens Healthcare Diagnostics Inc. Specific catalogue numbers.
MDA/2013/009 Nasogastric feeding tubes – Ryles tubes (weighted tip).  Manufactured by Vygon Ltd.  Size 12FG 125cm, product code: 392.12, lot number: 160412FG.  Size 14FG 125cm, product code: 392.14,  lot number: 100512FF.
MDA/2013/012 Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing, manufactured by• IND Diagnostics Inc, Canada• Alere International Ltd• Barrier Healthcare Ltd• E-Pharm Ltd
MDA/2013/015 Delivery System - Wound Sealant - EVICEL/QUIXIL Fibrin Sealant (Human)
MDA/2013/017 Infusion Systems Electrically Powered Infusion Pump
MDA/2013/022 Home use blood glucose meters: • Lifescan OneTouch Verio Pro • Lifescan OneTouch Verio IQ
MDA/2013/023 Workstation software for computed tomography systems Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3.  Manufactured by Vital Images, Inc.
MDA/2013/025 Home use blood glucose meter: FreeStyle InsuLinx manufactured by Abbott Diabetes Care
MDA/2013/026 Suction canisters and liners. All Receptal: 1 litre canisters (List number 43449), 1 litre PVC liners (List number OL212) and 1litre PE liners (List number OL213). Manufactured by Hospira (formerly manufactured by Abbott). All batch numbers.
MDA/2013/027 Peritoneal dialysis transfer sets.Manufactured by Baxter Healthcare Ltd. Product codes: R5C4325, R5C4326, R5C4482, R5C4483 and R5C4484. All batches.
MDA/2013/029 Airway Devices Tube Endotracheal
MDA/2013/031 Hospital beds: Dynamis and Gerialit with Dewert electrical control systems.  Manufactured by Hill-Rom.  Specific models numbers manufactured from October 1995 to June 2001 inclusive.
MDA/2013/033 Diacap® Ultra dialysis fluid filter.  Manufactured by   Product code: 7107366.  All devices that are more than 10 months from the date of manufacture are affected.
MDA/2013/034 Endoscopes, Rigid Laryngoscope
MDA/2013/035 Paradigm ambulatory insulin infusion pumps.  Models: MMT - 511, 512, 712, 712E, 515, 715, 522, 722, 722K, 523, 723, 723K, 554 (VEO) and 754 (VEO).
MDA/2013/038 Rusch Belly Bag urine collection bag with hip belt. Specific product codes. Manufactured by Teleflex Medical.
MDA/2013/039 Workstation software for computed tomography systems: Vitrea CT Brain Perfusion 2D application.  Versions 6.0 and above for Vitrea Enterprise Suite, Vitrea, VitreaAdvanced and Vitrea fX are affected.  Manufactured by Vital Images, Inc.
MDA/2013/040 Laboratory test kit. Orgentec Alegria dsDNA IgG (ORG204G) for the diagnosis of lupus.Lot numbers: 204G30204 and 204G30205.Manufactured by Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics.
MDA/2013/041 Laboratory test kit: Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption. Alegria Anti-Intrinsic Factor Assay (ORG-247-24) lot number 24723031 expiry 30/11/2013. Manufactured by Orgentec Diagnostika GmbH distributed in the UK by Launch Diagnostics.
MDA/2013/043 Rad-8 Pulse Oximeter with 20-pin patient cable connector. Manufactured by Masimo. Specific serial numbers are affected.
MDA/2013/046 Needle-free IV access device: Double Octopus extension set with 2 Bionectors, anti-reflux valves and clamps Manufactured by Vygon  Product code: 0841233  NHS Supply Chain code: FSW388  Lot numbers: 021112AF, 081112AF and 091112AF
MDA/2013/047 Safety blood collection and infusion sets.  Manufactured by Greiner Bio-One.
MDA/2013/048 Recall of Hospira 1 litre suction canisters and liners - additional products recalled. Suction canisters and liners with Abbott labels and list numbers are now included in the recall.
MDA/2013/049 Ibis Comfort wheelchair.  Manufactured by Handicare B.V.  Specific serial numbers of chairs manufactured from 29 January to 12 April 2013 inclusive.
MDA/2013/051 Overhead and Mobile Patient Hoists: Standard Sling Bar 450 (Spreader bar). Specific models numbers. Manufactured By Liko (A Hill-Rom Company).
MDA/2013/054R SLE 4000/5000 ventilator.Power supply unit (PSU) model FP110 – 410.Specific serial numbers.Manufactured by SLE.
MDA/2013/056 Infusion & Transfusion, Administration Sets Extension Set
MDA/2013/057 Spectra series powered wheelchairs. Manufactured by Invacare. Fitted with the Pilot+ digital wheelchair control system supplied by PG Drives Technology
MDA/2013/058 Blood grouping cassettes.  OrthoBioVue multi-reagent cassettes.  Manufactured by Ortho Clinical Diagnostics. Specific lots.
MDA/2013/059 Orthopaedic instrument. Flexible handle (part no. 355.280), used with the Simplified Universal Nail System (SUN) and the Universal Nail System (UNI). Synthes GmbH.
MDA/2013/061 Vacutainer® multiple sample Luer adaptor for blood sample collection.  Catalogue number 367300 (England only - NHS Supply Chain code KFK036). Specific lot numbers are affected.   Manufactured by Becton, Dickinson and Company (BD).
MDA/2013/062 Infusion pumps: Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Manufactured by CareFusion. Specific serial numbers are affected.
MDA/2013/063 TRACOE twist tracheostomy tubes. Manufactured by TRACOE Medical. Distributed in the UK by Kapitex Healthcare Ltd.
MDA/2013/064 Home use blood glucose test strips. GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter manufactured by Menarini. Lot 3212214249, expiry date 31-08-2014 and lot 3212219249, expiry date 31-08-2014.
MDA/2013/067 Infusion & Transfusion, Administration Sets Extension Set
MDA/2013/068 Single use syringes: PlastipakTM 50ml Luer Lok syringe – sterile. Manufactured by BD Medical. Product code 300865. Specific lot numbers.
MDA/2013/070 Insulin infusion sets and reservoirs used with Paradigm ambulatory insulin pumps (manufactured by Medtronic): 1) Paradigm infusion sets (all MMT models, all lot numbers). 2) Paradigm insulin reservoirs (MMT models - 326A and 332A, specific lots).
MDA/2013/071 Growth hormone pens.  NordiPen® used with 5mg and 10mg Norditropin® SimpleXx® (‘somatropin’) and NordiPenMate®.  Manufactured by Novo Nordisk.
MDA/2013/073 Pressure relieving air mattresses and overlays. All models and maufacturers.
MDA/2013/075 Vacutainer® multiple sample Luer adaptor for blood sample collection. Specific lot numbers affected.  Manufactured by Becton, Dickinson and Company (BD).
MDA/2013/076 Ultrasound, Imaging Accessory
MDA/2013/077 Receptal suction canisters and liners. Manufactured by Hospira (formerly manufactured by Abbott). All Abbott and Hospira list numbers are affected. All lot numbers and sizes are affected.
MDA/2013/079 Intravenous administration sets: Primary PlumSet Clave secondary port.  Manufactured by Hospira.  Specific list numbers are affected.
MDA/2013/080 Perfusor Space infusion pump.
MDA/2013/081R Infusion & Transfusion, Administration Sets Filter
MDA/2013/083 TransRadial artery access kit. Manufactured by Arrow International (a division of Teleflex Medical). Specific part numbers and lot numbers. TransRadial artery access kit. Manufactured by Arrow International (a division of Teleflex Medical). Specific part numbers and lot numbers.
MDA/2014/002 Workstation software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5). Manufactured by Vital Images. Workstation  software for computed tomography systems: VitreaCore® software versions 6.0 to 6.5 inclusive, including all upgrades (except 6.3.1, 6.4.4 and 6.4.5). Manufactured by Vital Images.
MDA/2014/007 Peristeen anal irrigation system manufactured by Coloplast Limited.
MDA/2014/009 FreeStyle Mini® and FreeStyle® blood glucose monitoring systems manufactured by Abbott Diabetes Care.
MDA/2014/013 S74 Elite Sport Scooter with Leoch 20 amp/hour batteries. Manufactured by Pride Mobility Products Ltd. Specific serial numbers.

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