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Summary List of field safety notices (FSNs) from medical device manufacturers from 03 to 07 December 2018
- Alert type:
- Field safety notice
- Issued:
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 November 2018
- Alert type:
- Field safety notice
- Issued:
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
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Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
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List of field safety notices (FSNs) from medical device manufacturers from 19 November to 23 November
- Alert type:
- Field safety notice
- Issued:
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List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November
- Alert type:
- Field safety notice
- Issued:
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Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 3 others
- Issued:
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Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
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List of field safety notices (FSNs) from medical device manufacturers from 05 November to 09 November
- Alert type:
- Field safety notice
- Issued:
-
The above batch is being recalled because an out of specification result for sub visible particles was recorded at the 39 month time point
- Alert type:
- Drug alert: company-led
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 29 October to 02 November
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 22 October to 26 October
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 15 October to 19 October
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 8 October to 12 October
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 1 October to 5 October
- Alert type:
- Field safety notice
- Issued:
-
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
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Allergan Pharmaceuticals Ireland is recalling specific batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.
- Alert type:
- Drug alert
- Medical specialism:
- Ophthalmology
- Issued:
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List of field safety notices (FSNs) from medical device manufacturers from 24 September to 28 September
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 17 September to 21 September
- Alert type:
- Field safety notice
- Issued:
-
Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2028 – wire may breach packaging, compromising sterility of device.
- Alert type:
- Medical device alert
- Medical specialism:
- General surgery and 3 others
- Issued:
-
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
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Haematology and oncology
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Manufactured by Halyard Health – risk of some Flex Connectors in Closed Suction Kits becoming loose or disconnecting, which may interrupt patient ventilation.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 2 others
- Issued:
-
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.
- Alert type:
- Drug alert
- Medical specialism:
- Critical care and 2 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 10 September to 14 September
- Alert type:
- Field safety notice
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- General surgery and 3 others
- Issued:
-
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.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Ophthalmology
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 03 September to 20 September 2018.
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 28 August to 31 August
- Alert type:
- Field safety notice
- Issued:
-
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
- Alert type:
- Drug alert
- Medical specialism:
- Pharmacy
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 20 August to 24 August
- Alert type:
- Field safety notice
- Issued:
-
B.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- General surgery
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 13 August to 17 August
- Alert type:
- Field safety notice
- Issued:
-
B.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- General surgery
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 6 August to 10 August
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 30 July to 3 August 2018
- Alert type:
- Field safety notice
- Issued:
-
Manufactured by Newdeal SAS – Risk of infection from compromised packaging.
- Alert type:
- Medical device alert
- Medical specialism:
- Orthopaedics
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 July 2018
- Alert type:
- Field safety notice
- Issued:
-
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.
- Alert type:
- Drug alert
- Medical specialism:
- Pharmacy
- Issued:
-
UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
- Alert type:
- Medical device alert
- Medical specialism:
- Cosmetic surgery and 4 others
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 June to 20 July 2018.
- Alert type:
- Field safety notice
- Issued:
-
Manufactured by Smith & Nephew – The device has a higher than expected risk of revision due to early component loosening.
- Alert type:
- Medical device alert
- Medical specialism:
- Orthopaedics
- Issued:
-
IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
- Alert type:
- Drug alert: company-led
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
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Summary List of field safety notices (FSNs) from medical device manufacturers from 09 June to 13 July 2018.
- Alert type:
- Field safety notice
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 28 May to 1 June 2018.
- Alert type:
- Field safety notice
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 2 others
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
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.
- Alert type:
- Drug alert
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 July 2018.
- Alert type:
- Field safety notice
- Issued:
-
Novo Nordisk is recalling one batch as a precautionary measure due to the presence of particles in a small number of samples.
- Alert type:
- Drug alert
- Issued:
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