Alerts and recalls for drugs and medical devices

List of field safety notices (FSNs) from medical device manufacturers from 08 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

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

Alert type:

Field safety notice

Issued:

11 February 2019

Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery.

Alert type:

Medical device alert

Issued:

8 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019

Alert type:

Field safety notice

Issued:

14 January 2019

List of field safety notices (FSNs) from medical device manufacturers from 28 January to 1 February 2019

Alert type:

Field safety notice

Issued:

4 February 2019

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:

4 February 2019

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:

30 January 2019

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:

30 January 2019

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:

25 January 2019

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:

29 January 2019

List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 January 2019

Alert type:

Field safety notice

Issued:

28 January 2019

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:

24 January 2018

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 January 2019

Alert type:

Field safety notice

Issued:

21 January 2019

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:

17 January 2018

List of field safety notices (FSNs) from medical device manufacturers from 31 December 2018 to 4 January 2019

Alert type:

Field safety notice

Issued:

7 January 2019

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:

3 January 2018

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:

24 December 2018

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:

21 December 2018

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:

18 December 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 03 to 07 December 2018

Alert type:

Field safety notice

Issued:

10 December 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 November 2018

Alert type:

Field safety notice

Issued:

4 December 2018