GovWire

Field Safety Notices: 7 to 11 September 2020

Medicines Healthcare Products Regulatory Agency

September 14
11:16 2020

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014 FSNs before this date are on the National Archives website

Across: Revolax, Dermalax, dermaren

1 September 2020

Implants, reconstructive, body contouring

MHRA reference 2020/008/031/601/001

Advanced Medical Solutions: ACTIVHEAL Hydrogel

02 September 2020

Haemostatic agents

Model: 10014007

MHRA reference 2020/008/011/601/008

Armstrong Medical: Catheter Mounts

10 September 2020

Breathing system components

MHRA reference: 2020/008/018/487/011

Caesarea Medical Electronics: T34 Ambulatory Syringe Pump

07 September 2020

Infusion systems

MHRA reference: 2020/009/008/487/001

Getinge - MAQUET: mobile OR-Table MEERA, YUNO und YUNO II

2020-09-08

2020-010

Operating table

Model: 720001B2, 720001B0, 720001F2, 720001F0, 710001B2, 710001B0, 143301B0, 143301F0, 143302B0, 143302F0

MHRA reference: 2020/009/009/701/026

ICU Medical: Spiros

08 September 2020

Infusion & transfusion, connectors

MHRA reference: 2020/009/004/701/026

Medtronic: Rashkind Balloon Septostomy Catheters

September 2020

Vascular cannula and catheters

Model: 007160, 007161, 008764

MHRA reference: 2020/009/010/487/004

Micro Therapeutics (Medtronic): PipelineTM Flex Embolization Device (with Shield TechnologyTM)

September 2020

Intracranial flow diverters / stents

Model: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX, PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX

MHRA reference: 2020/009008/487/002

NRS Healthcare: Hearing aid

4 September 2020

Disabled peoples aids

MHRA reference: 2019/011/006/291/003

Nouvag AG: MD11 / MD30

11 August 2020

Dental, laboratory equipment

MHRA reference: 2020/009/009/487/007

Olympus: OES CHOLEDOCHOFIBERSCOPE - OLYMPUS CHF TYPE CB30S

September 2020

Endoscopes, flexible

Model: CHF-CB30S

MHRA reference: 2020/009/010/291/001

Philips: Efficia DFM 100

11 August 2020

Defibrillators, non-Implantable

Model: 866199

MHRA reference: 2020/009/004/291/006

Pressalit A/S: VALUE II

08 September 2020

Bath and aids

Model: R1610

MHRA reference: 2020/009/009/601/003

Siemens: ADVIA Centaur HER-2/neu (H2n) Assay and ADVIA Centaur

August 2020

IVDs, clinical chemistry

MHRA reference: 2020/009/003/601/009

Thermo Fisher: Oxoid

03 September 2020

IVDs, bacteriology

Model: CT0034B

MHRA reference: 2020/009/004/601/006

Vascular Solutions (Teleflex)

08 September 2020

Vascular cannula and catheters

Model: 5515; 5540; 5545; 5550

MHRA reference: 2020/009/010/701/012

Published 14 September 2020

Recent Comments

Follow Us on Twitter

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: