Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 2021

• Alert type: Field safety notice
• Issued: 19 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021

• Alert type: Field safety notice
• Issued: 19 April 2021

Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.

• Alert type: Device safety information
• Issued: 6 April 2021

List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 April 2021.

• Alert type: Field safety notice
• Issued: 6 April 2021

List of field safety notices (FSNs) from medical device manufacturers from 22 March to 26 March 2021.

• Alert type: Field safety notice
• Issued: 29 March 2021

There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles

• Alert type: Device safety information
• Issued: 29 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 March 2021.

• Alert type: Field safety notice
• Issued: 22 March 2021

Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.

• Medical specialism: Pharmacy
• Issued: 18 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 March 2021

• Alert type: Field safety notice
• Issued: 15 March 2021

Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).

• Medical specialism: Pharmacy
• Issued: 15 March 2021

BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.

• Alert type: National patient safety alert
• Medical specialism: Anaesthetics and 21 others
• Issued: 11 March 2021

Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).

• Medical specialism: Pharmacy
• Issued: 9 March 2021

List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 March 2021

• Alert type: Field safety notice
• Issued: 8 March 2021

The MHRA has made further changes to the way we issue safety messaging to healthcare providers.

• Issued: 1 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 February 2021

• Alert type: Field safety notice
• Issued: 1 March 2021

Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.

• Medical specialism: Pharmacy
• Issued: 1 March 2021

Unknown risks following distribution of product after CE certificate withdrawal

• Alert type: Device safety information
• Medical specialism: Orthopaedics
• Issued: 26 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021

• Alert type: Field safety notice
• Issued: 22 February 2021

The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia remains unchanged.

• Alert type: Device safety information
• Medical specialism: Cardiology and 2 others
• Issued: 18 February 2021

SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).

• Medical specialism: Pharmacy
• Issued: 17 February 2021

Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.

• Medical specialism: Anaesthetics and 21 others
• Issued: 16 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 February 2021

• Alert type: Field safety notice
• Issued: 15 February 2021

The MHRA publishes several types of information about medical devices on GOV.UK

• Alert type: Device safety information
• Issued: 12 February 2021

Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…

• Medical specialism: Anaesthetics and 21 others
• Issued: 11 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 February 2021

• Alert type: Field safety notice
• Issued: 8 February 2021

Grünenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.

• Medical specialism: General practice and 1 others
• Issued: 8 February 2021

Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity …

• Issued: 3 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 January 2021

• Alert type: Field safety notice
• Issued: 1 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2021

• Alert type: Field safety notice
• Issued: 26 January 2021

CSL Behring UK Ltd is recalling specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling pro…

• Medical specialism: Pharmacy
• Issued: 20 January 2021

Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the fini…

• Medical specialism: Pharmacy
• Issued: 18 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2021

• Alert type: Field safety notice
• Issued: 18 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 04 January to 08 January 2021

• Alert type: Field safety notice
• Issued: 11 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 28 December to 31 December 2020

• Alert type: Field safety notice
• Issued: 4 January 2021

List of field safety notices (FSNs) from medical device manufacturers from 21 December to 24 December 2020

• Alert type: Field safety notice
• Issued: 29 December 2020

Medac Pharma LLP is recalling specific batches of products due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.

• Medical specialism: Pharmacy
• Issued: 29 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 14 December to 18 December 2020

• Alert type: Field safety notice
• Issued: 21 December 2020

Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a…

• Medical specialism: Pharmacy
• Issued: 18 December 2020

Merck Sharp & Dohme Limited is recalling specific batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion as a precautionary measure due to the presence of Ralstonia pickettii in recent batches m…

• Medical specialism: Pharmacy
• Issued: 16 December 2020

Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the…

• Issued: 15 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 07 December to 11 December 2020

• Alert type: Field safety notice
• Issued: 14 December 2020

Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.

• Medical specialism: Pharmacy
• Issued: 14 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2020.

• Alert type: Field safety notice
• Issued: 7 December 2020

Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.

• Medical specialism: Pharmacy
• Issued: 3 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2020.

• Alert type: Field safety notice
• Issued: 30 November 2020

Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide

• Medical specialism: Pharmacy
• Issued: 26 November 2020

Kent Pharmaceuticals Ltd has informed us that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the fi…

• Medical specialism: Pharmacy
• Issued: 26 November 2020

Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of double tablets in a single blister pocket.

• Medical specialism: Pharmacy
• Issued: 25 November 2020

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2020.

• Alert type: Field safety notice
• Issued: 23 November 2020

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 2020.

• Alert type: Field safety notice
• Issued: 16 November 2020