-
Pagewriter Cardiographs (TC20/30/50/70) manufactured before 20 November 2018 and Efficia Monitors (CM10/12/100/120/150) manufactured before 25 October 2018 – risk of batteries overheating or igniting (MDA/2019/017)
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:
-
enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer (MDA/2019/016)
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:
-
Field Safety Notice: 11 to 15 March 2019
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 March 2019
- Alert type:
- Field safety notice
- Issued:
-
Company-led drug alert - Ozurdex implant recall (MDR 95-08/18)
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:
-
Field Safety Notice: 4 to 8 March 2019
List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 March 2019
- Alert type:
- Field safety notice
- Issued:
-
enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device (MDA/2019/015)
[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:
-
Field Safety Notices - 25 February 2019 - 1 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:
-
All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed (MDA/2019/014)
Manufactured by C.R.
- Alert type:
- Medical device alert
- Medical specialism:
- Obstetrics and gynaecology and 2 others
- Issued:
-
All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035)
[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:
-
All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues (MDA/2019/013)
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:
-
Drug Alert Class 4: Paracetamol Infusion, Accord. (MDR 07-02/19)
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:
-
Potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps (MDA/2019/012)
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:
-
Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 – risk of loss of patient monitoring (MDA/2019/011)
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:
-
Field Safety Notice: 18 to 22 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 18-22 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy
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:
-
Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons
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:
-
Field Safety Notice: 11 to 15 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19)
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:
-
Implantable cardiac pacemakers: specific brands of dual chamber pacemakers - risk of syncope due to pause in pacing therapy (MDA/2019/008)
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:
-
Ophthalmic implant Raindrop Near Vision Inlay – risk of corneal haze (MDA/2019/007)
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:
-
Class 2 Medicines recall: Actavis Group PTC EHF - Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 (MDR 94-06/18)
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:
-
Field Safety Notice: 4 to 8 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Orthopaedic implant rHead Radial Head and Uni-Elbow: risk of early loosening (MDA/2019/006)
Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery.
- Alert type:
- Medical device alert
- Issued:
-
Field Safety Notice: 7-11 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Field Safety Notices: 28 January to 1 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 28 January to 1 February 2019
- Alert type:
- Field safety notice
- Issued:
-
Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18)
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:
-
Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005)
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:
-
Arjo Minstrel passive floor lift (portable hoist) – risk of spreader bar detachment from lifts without a scale (MDA/2019/004)
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:
-
Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (MDA/2019/002)
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:
-
FreeStyle Libre flash glucose sensor – Use of barrier methods to reduce skin reactions to the sensor adhesive (MDA/2019/003)
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:
-
Field Safety Notices: 21 to 25 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18)
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:
-
Field Safety Notices: 14 to 18 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension (MDA/2019/001)
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:
-
Field Safety Notice: 31 December 2018 to 4 January 2019
List of field safety notices (FSNs) from medical device manufacturers from 31 December 2018 to 4 January 2019
- Alert type:
- Field safety notice
- Issued:
-
Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets
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:
-
Field Safety Notice - 17 - 21 December 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:
-
Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation (MDA/2018/037)
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:
-
Field Safety Notice - 10 - 14 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:
-
Field safety notices - 03 to 07 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:
-
Field safety notices - 26 to 30 November 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 November 2018
- Alert type:
- Field safety notice
- Issued:
-
Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products
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:
-
Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.
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:
-
Field Safety Notice - 19 November to 23 November 2018
List of field safety notices (FSNs) from medical device manufacturers from 19 November to 23 November
- Alert type:
- Field safety notice
- Issued:
-
Field Safety Notice - 12 November to 16 November
List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November
- Alert type:
- Field safety notice
- Issued:
-
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.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
-
Field Safety Notice - 05 November to 09 November
List of field safety notices (FSNs) from medical device manufacturers from 05 November to 09 November
- Alert type:
- Field safety notice
- Issued:
-
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
- Alert type:
- Drug alert: company-led
- Issued:
-
Field Safety Notice - 29 October to 02 November
List of field safety notices (FSNs) from medical device manufacturers from 29 October to 02 November
- Alert type:
- Field safety notice
- Issued:
-
Field Safety Notice - 22 October to 26 October
List of field safety notices (FSNs) from medical device manufacturers from 22 October to 26 October
- Alert type:
- Field safety notice
- Issued:
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