Alerts and recalls for drugs and medical devices

List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 June 2019

Alert type:

Field safety notice

Issued:

17 June 2019

M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.

Alert type:

Drug alert

Medical specialism:

Pharmacy

Issued:

13 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 June 2019

Alert type:

Field safety notice

Issued:

10 June 2019

Recommendations following publicised concerns over an increase in patient mortality from two years after treatment.

Alert type:

Medical device alert

Medical specialism:

General surgery and 2 others

Issued:

4 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 May 2019

Alert type:

Field safety notice

Issued:

3 June 2019

Baxter Healthcare Limited has informed us that a quality defect has been identified with the above product where the front panel of a small number of infusion bags was found to be missing the red text.

Alert type:

Drug alert

Issued:

3 June 2019

Manufactured by GE Healthcare – device may fail to deliver the set agent concentration in End Tidal Control mode.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 1 others

Issued:

30 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 20 to 25 May 2019

Alert type:

Field safety notice

Issued:

29 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 May 2019

Alert type:

Field safety notice

Issued:

20 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 7 to 10 May 2019.

Alert type:

Field safety notice

Issued:

13 May 2019

Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle.

Alert type:

Drug alert

Issued:

13 May 2019

Macopharma is recalling certain batches of intravenous infusion bags as a precaution.

Alert type:

Drug alert: company-led

Issued:

7 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 29 April to 3 May 2019.

Alert type:

Field safety notice

Issued:

7 May 2019

Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. Update includes further advice on how to detect features of Nellix endograft failures.

Alert type:

Medical device alert

Medical specialism:

Radiology and 1 others

Issued:

1 May 2019

Manufactured by Etac and supplied in UK by R82 UK Ltd – if the hooks connecting the spreader bar to the hoist break during use, the patient could fall.

Alert type:

Medical device alert

Medical specialism:

Care home staff and 1 others

Issued:

1 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 23 to 26 April 2019.

Alert type:

Field safety notice

Issued:

29 April 2019

Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg.

Alert type:

Drug alert

Issued:

26 April 2018

Manufactured by Ethicon – use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding.

Alert type:

Medical device alert

Medical specialism:

General surgery and 2 others

Issued:

25 April 2019

Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules.

Alert type:

Drug alert

Issued:

24 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 April 2019

Alert type:

Field safety notice

Issued:

23 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 April 2019

Alert type:

Field safety notice

Medical specialism:

Orthopaedics and 1 others

Issued:

15 April 2019

Martindale Pharmaceuticals has informed us of two issues with all unexpired batches of the above product, PL 00156/0109, legal status ‘P’.

Alert type:

Drug alert

Issued:

9 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 April 2019

Alert type:

Field safety notice

Medical specialism:

Anaesthetics and 1 others

Issued:

4 April 2019

B.

Alert type:

Drug alert

Medical specialism:

Critical care and 1 others

Issued:

8 April 2019

Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, has informed us that some packs from a batch of Zoledronic acid 5mg solution for infusion contain a Patient Information Leaflet for Temozolomide 180mg Capsules.

Alert type:

Drug alert

Issued:

4 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 March.

Alert type:

Field safety notice

Issued:

1 April 2019

Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.

Alert type:

Medical device alert

Issued:

29 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 March 2019.

Alert type:

Field safety notice

Issued:

25 March 2019

Further to previous recalls of Valsartan and Irbesartan containing products, which were potentially contaminated with N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), we have become aware of products containing Losartan Potassium that are contaminated with a different nitrosamine, N-nitroso-N-methylamino butyric acid (NMBA). Losartan Potassium containing products from Accord Healthcare Limited are affected and the batches listed above are being recalled.

Alert type:

Drug alert

Issued:

20 March 2019

Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 16 others

Issued:

20 March 2019

Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 14 others

Issued:

19 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 March 2019

Alert type:

Field safety notice

Issued:

19 March 2019

Allergan Pharmaceuticals Ireland is further recalling batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.

Alert type:

Drug alert: company-led

Issued:

18 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 March 2019

Alert type:

Field safety notice

Issued:

11 March 2019

[Archived] Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 14 others

Issued:

19 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 25 February 2019 - 1 March 2019

Alert type:

Field safety notice

Issued:

4 March 2019

Manufactured by C.R.

Alert type:

Medical device alert

Medical specialism:

Obstetrics and gynaecology and 2 others

Issued:

7 March 2018

[Archived]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:

14 November 2018

Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – instructions provided to reduce the risk of delay to therapy and loss of infusion if the battery loses connection.

Alert type:

Medical device alert

Issued:

4 March 2019

Accord Healthcare Limited has informed us that there is an error on the portion of the Patient Information Leaflet (PIL) for the Paracetamol Infusion which is intended for Healthcare Professionals.

Alert type:

Drug alert

Medical specialism:

General surgery

Issued:

28 February 2019

Manufactured by ConvaTec Limited - use of affected devices may increase risk of patients acquiring infections – extension to MDA/2018/034 as additional devices are affected

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 15 others

Issued:

28 February 2019

Manufactured by GE Healthcare - If networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 14 others

Issued:

27 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 18-22 February 2019

Alert type:

Field safety notice

Issued:

25 February 2019

Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered.

Alert type:

Medical device alert

Medical specialism:

Anaesthetics and 18 others

Issued:

20 February 2019

Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).

Alert type:

Medical device alert

Medical specialism:

Care home staff and 4 others

Issued:

19 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 2019

Alert type:

Field safety notice

Issued:

18 February 2019

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:

18 February 2019

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:

13 February 2019

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:

13 February 2018

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:

13 February 2014