Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2021 – 31.03.2021

https://www.gov.uk/drug-device-alerts

https://www.gov.uk/drug-device-alerts?page=2

 

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

 Issued: 29 March 2021

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

 Issued: 29 March 2021

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

 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.

 Issued: 18 March 2021

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

 Issued: 15 March 2021

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

 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.

 Medical specialism: Anaesthetics and 21 others

 

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

 Issued: 9 March 2021

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

 Issued: 8 March 2021

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

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

 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.

 Issued: 1 March 2021

Unknown risks following distribution of product after CE certificate withdrawal

 Medical specialism: Orthopaedics

 Issued: 26 February 2021

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

 Issued: 22 February 2021

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

 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).

 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.

 Issued: 16 February 2021

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

 Issued: 15 February 2021

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

 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-…

 Issued: 11 February 2021

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

 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.

 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 …

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

 Issued: 1 February 2021

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

 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…

 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…

 Issued: 18 January 2021

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

 Issued: 18 January 2021

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