-
Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 5 others
- Issued:
-
Manufactured by ReVision Optics, Inc – patients implanted with this device have an increased risk of corneal haze.
- Alert type:
- Medical device alert
- Medical specialism:
- General practice and 2 others
- Issued:
-
Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery.
- Alert type:
- Medical device alert
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 28 January to 1 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Accord Healthcare Limited has informed us that that a change to the Patient Information Leaflet (PIL) for
this product has not been implemented by the required timeline.
- Alert type:
- Drug alert
- Medical specialism:
- Pharmacy
- Issued:
-
Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 1 others
- Issued:
-
Endologix has stopped selling the Nellix EVAS device and is recalling unused stock.
- Alert type:
- Medical device alert
- Medical specialism:
- Radiology and 1 others
- Issued:
-
Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 3 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Manufactured by GE Healthcare – Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 8 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 31 December 2018 to 4 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
- Alert type:
- Drug alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
- Alert type:
- Field safety notice
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by Acutronic Medical Systems AG – Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 3 others
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
- Alert type:
- Field safety notice
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 03 to 07 December 2018
- Alert type:
- Field safety notice
- Issued:
-
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 November 2018
- Alert type:
- Field safety notice
- Issued:
-
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:
-
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:
-
List of field safety notices (FSNs) from medical device manufacturers from 19 November to 23 November
- Alert type:
- Field safety notice
- Issued:
-
List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November
- Alert type:
- Field safety notice
- Issued:
-
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:
-
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:
-
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:
-
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:
GOV.UK