GOV.UK
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All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035)
Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
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Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging (MDA/2018/034)
Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.
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Field Safety Notice - 05 November to 09 November
List of field safety notices (FSNs) from medical device manufacturers from 05 November to 09 November
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Mitomycin-C Kyowa: Company-led Drug Alert
The above batch is being recalled because an out of specification result for sub visible particles was recorded at the 39 month time point
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Field Safety Notice - 29 October to 02 November
List of field safety notices (FSNs) from medical device manufacturers from 29 October to 02 November
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Field Safety Notice - 22 October to 26 October
List of field safety notices (FSNs) from medical device manufacturers from 22 October to 26 October
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Field Safety Notice - 15 October to 19 October
List of field safety notices (FSNs) from medical device manufacturers from 15 October to 19 October
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Field Safety Notice - 8 October to 12 October
List of field safety notices (FSNs) from medical device manufacturers from 8 October to 12 October
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Field Safety Notice - 1 October to 5 October
List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October
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CoaguChek Test Strips for Point of Care and Home Use – risk of false high results (MDA/2018/033)
Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions
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Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18)
Allergan Pharmaceuticals Ireland is recalling specific batches due to the possibility that a single loose silicone particle of approximately 300microns in diameter may become detached.
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Field Safety Notice - 24 September to 28 September
List of field safety notices (FSNs) from medical device manufacturers from 24 September to 28 September
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Field Safety Notice - 17 September to 21 September
List of field safety notices (FSNs) from medical device manufacturers from 17 September to 21 September
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Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032)
Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2028 – wire may breach packaging, compromising sterility of device.
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Imatinib 400mg Capsules (3 x 10) PL 36390/0180 : Company-led Drug Alert
Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect
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SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018: risk of batteries overheating or igniting (MDA/2018/031)
Manufactured by Philips – Lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.
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Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation (MDA/2018/030)
Manufactured by Halyard Health – risk of some Flex Connectors in Closed Suction Kits becoming loose or disconnecting, which may interrupt patient ventilation.
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Class 4 defect information: Caspofungin 70mg powder for concentrate for solution for infusion (MDR 11-09/18)
Cadiasun Pharma GmBH has informed us that there is an error on the patient information leaflet for Caspofungin 70mg powder for concentrate for solution for infusion.
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Field Safety Notice - 10 September to 14 September
List of field safety notices (FSNs) from medical device manufacturers from 10 September to 14 September
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BenchMark Automated Slide Stainer series – FLO LOK III Reagent Dispenser Issue for IHC and ISH kits including INFORM HPV III Family 16 Probe (B) (MDA/2018/029)
Roche (Ventana Medical Systems) has released an expansion of products affected by the reagent dispenser issues causing weak staining and the potential for false negative results and misdiagnosis.
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Mydriasert 0.28mg/5.4mg Ophthalmic Insert: Company-led recall
Thea Pharmaceuticals are recalling a specific batch of Mydriasert 0.28mg/5.4mg Ophthalmic Insert as it is labelled as being for the French market, rather than the UK market.
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Field safety notices - 03 to 07 September 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 03 September to 20 September 2018.
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Field Safety Notice - 28 to 31 August
List of field safety notices (FSNs) from medical device manufacturers from 28 August to 31 August
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Class 4 defect information: Olmetec 20mg Film Coated Tablets (MDR 12-08/18)
Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of specific batches of Olmetec 20mg Film-Coated Tablets
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Field Safety Notice - 20 to 24 August
List of field safety notices (FSNs) from medical device manufacturers from 20 August to 24 August
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Nutriflex Lipid Special without Electrolytes 2500ml: Company-led recall
B.
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Field Safety Notice - 13 August to 17 August
List of field safety notices (FSNs) from medical device manufacturers from 13 August to 17 August
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Nutriflex Omega Special 2500ml: Company-led recall
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Field Safety Notice - 6 August to 10 August
List of field safety notices (FSNs) from medical device manufacturers from 6 August to 10 August
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Field Safety Notice - 30 July to 3 August
List of field safety notices (FSNs) from medical device manufacturers from 30 July to 3 August 2018
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Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection (MDA/2018/028)
Manufactured by Newdeal SAS – Risk of infection from compromised packaging.
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Field Safety Notice - 23 to 27 July 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 July 2018
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Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17)
FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles.
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Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated - Anaplastic Large Cell Lymphoma (MDA/2018/027)
UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
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Field safety notices - 16 to 20 July 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 June to 20 July 2018.
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First generation JOURNEY BCS Knee System– Higher than expected risk of revision (MDA/2018/026)
Manufactured by Smith & Nephew – The device has a higher than expected risk of revision due to early component loosening.
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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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