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Melatonin 10mg capsules: Company-led recall
IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
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Field safety notices - 09 to 13 July
Summary List of field safety notices (FSNs) from medical device manufacturers from 09 June to 13 July 2018.
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Field safety notices - 28 May to 1 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 28 May to 1 June 2018.
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Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use (MDA/2018/025R)
Manufactured by Vital Healthcare Sdn for distribution by Baxter Healthcare Ltd – specific product codes manufactured in 2017 have functional and assembly issues which may lead to air entering the system, blood loss, clotting and delays in treatment.
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All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine (MDA/2018/024R)
Manufactured by CareFusion, now Becton Dickinson (BD) Medical – identify and replace the back-plate in the plunger assembly and note updated preventative maintenance schedule for these pumps.
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Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall
Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord) and Dexcel Pharma Ltd due to contamination.
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Field safety notices - 2 to 6 July 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 July 2018.
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Class 2 Medicines Recall: Fiasp FlexTouch 100 units/mL solution for injection pre-filled pen manufactured by Novo Nordisk (MDR 065-06/18)
Novo Nordisk is recalling one batch as a precautionary measure due to the presence of particles in a small number of samples.
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SAM XT Extremity Tourniquet - Recall due to the risk of tourniquet failing in use
Manufactured by SAM Medical Products - An error in the manual sewing operations of devices manufactured from March 2017 to April 2018 may cause the seam holding the buckle to the belt to fail.
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Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser
Manufactured by Roche Diagnostics GmbH – Incorrect Limit of Detection (LoD) for protein, nitrite, ketone bodies, leukocytes, blood: intact erythrocytes, which may adversely impact patient treatment.
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Field safety notices - 25 to 29 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 June 2018.
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Field Safety Notice - 18 to 22 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 June 2018.
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Denzapine 50mg/ml Oral Suspension - company led recall
Britannia Pharmaceuticals Ltd has issued a company-led drug alert for Denzapine 50mg/ml Oral Suspension (CLDA (18)A/03)
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Alaris Smartsite Add-On Bag Access device – removal and destruction of specific batches due to risk of disconnection or leakage (MDA/2018/021)
Manufactured by BD (formerly Carefusion) – specific batches manufactured from July 2015 to Sept 2016 inclusive. Risk of leakage or disconnection of tubing caused by inadequately sealed connections.
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Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs – recall of specific lots due to risk of under delivery of medication
Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate which could cause partial or total occlusion of the tubing with no alarm.
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Class 2 Medicines Recall:Own-brand children’s glycerine and blackcurrant cough syrups manufactured by Bell, Sons & Co.
Bell, Sons & Co is recalling several batches of own-brand children’s blackcurrant cough syrups due to a small number of reports of mould.
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Field Safety Notice - 11 to 15 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 June 2018.
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Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046
Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
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Field Safety Notice - 04 to 08 June 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 June 2018.
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JM103 and JM105 Jaundice Meters – risk of misinterpretation of measurement in hyperbilirubinemia cases.
Draeger Medical Systems – misinterpretation of display may cause delay of treatment of neonatal jaundice.
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Various Arrow Critical Care devices – recall due to incomplete packaging seals
Manufactured by Teleflex – various critical care devices manufactured from January to December 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
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Field safety notices - 21 - 25 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 May 2018.
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Cook Vacuum Pump for IVF – risk of electric shock or burn to operator
Manufactured by Cook Medical – risk of electric shock or burn, and failure of the device to operate during IVF procedures because of non-compliant mains wiring.
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Field Safety Notice - 14 to 18 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 May 2018.
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Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results
Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.
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Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension - company led recall
Rosemont Pharmaceuticals Limited, MS 427 is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension (CLDA (18)A/02).
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Gambro Ultrafilter U9000 microbial water filter – updated instructions due to leaks during use resulting in risk of hypovolemia.
Manufactured by Baxter Healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia
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Field Safety Notice - 07 to 11 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 07 to 11 May 2018.
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Field Safety Notice - 30 April to 04 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 April to 04 May 2018.
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Field Safety Notice - 9 to 13 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 April 2018.
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Class 3 Medicines Recall: Latanoprost Timolol Eye drops
FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
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Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated
Manufactured by Draeger – a software issue may prevent the activation of audible and visual invasive blood pressure measurement alarms, risking a delay to treatment
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cobas b 221 instruments with AutoQC module – software limitation affecting automatic QC measurements
Manufactured by Roche Diagnostics GmbH – Under specific circumstances scheduled automatic QC measurements may no longer be performed and erroneous patient results may remain undetected.
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Field Safety Notice - 23 to 27 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 April 2018.
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BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes – risk of incorrect results for lead testing or other assays using ASV methodology
Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology.
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Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision
Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
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Field Safety Notice - 16 to 20 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 April 2018.
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Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)
Caution in Use: Distribute to Pharmacy and Clinic Level.
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Field Safety Notice - 02 to 06 April 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 April 2018
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Field Safety Notice - 26 to 30 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 March to the 30 March 2018
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All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment
Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)
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Mesna 100mg/ml solution for injection/infusion, 5 x 4ml - company led recall
Claris Lifesciences UK Limited are issuing a company-led drug alert for one batch of Mesna 100mg/ml solution for injection/infusion, 5 x 4ml due to stability issues (CLDA (18)A/01)
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Field Safety Notice - 19 to 23 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 March 2018
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Field Safety Notice - 12 to 16 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 March 2018
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Field Safety Notice - 5 to 9 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 March 2018
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Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)
AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit.
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Medical device alerts archived in March 2018
Following our latest review of medical device alerts, we have archived the ones listed below.
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Field Safety Notice - 26 February – 02 March 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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Bag valve mask (BVM) manual resuscitation system – risk of damage to lungs by delivery of excessive pressure
Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)
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Field Safety Notice - 19 to 23 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 February 2018
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