Field Safety Notice: 16 to 20 December 2019

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.

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

Aesculap SZ380R: ENNOVATE MIS ENTFERNUNGSSCHLÜSSEL KURZ

18 December 2019

Orthopaedic surgical instruments - Insertion/extraction tools

Model: SZ380R

MHRA reference: 2019/012/018/701/015

Aesculap PL730SU: CAIMAN

18 December 2019

Surgical, diathermy

Model: PL730SU

MHRA reference: 2019/012/018/701/014

Bedfont Scientific: NObreath V2

04 December 2019

Gas vapour analysers

MHRA reference: 2019/012/019/291/005

Bock: Domiflex Niedrig Classic

14 November 2019

Beds and accessories

Model: 263

MHRA reference: 2019/012/010/701/035

CME (Becton): T34 TM Ambulatory Syringe Pump

12 December 2019

Infusion systems

MHRA reference: 2019/012/016/291/016

Covidien (Medtronic): Biosyntm: UM201

December 2019

Sutures

Model: Polysorbtm: CL915; CL914; CL923; CL925; UL203; SL5690; CL461; CL537; CL811; CL815; CL885; CL911; CL953; GL123; GL124; GL228; GL323; GLS322; L1742K; L2752K; SL1625G; SL5679; SL654; UL877; UL878

MHRA reference: 2019/012/019/487/001

Depuy Synthes: Sterile Tube Packaging

18 December 2019

Osteosynthesis, bone screws

MHRA reference: 2019/012/018/291/019

Fast Track Diagnostics: Various FTD Products

December 2019

IVDs, bacteriology

MHRA reference: 2019/012/016/291/017

Fast Track Diagnostics (FA-2019-19): FTD Respiratory pathogens 21

December 2019

IVDs, bacteriology

MHRA reference: 2019/012/019/291/004

Karl Storz: Autocon

18 December 2019

Surgical, diathermy

Model: UH300, UH300U, UH400, UH400U, UH401, UH401U

MHRA reference: 2019/012/019291/001

Medifab: Shuttle Discovery Verve Stroller

20 September 2019

Buggies for disabled people

MHRA reference: 2019/012/012/291/001

Philips Medical Systems: Azurion system, R1.2.x and R2.0.x

12 December 2019

X Ray, fluoroscopy systems

Model: 722063, 722064, 722065, 722066, 7722067, 722068, 722078, 722079, 722302, 722303, 722136

MHRA reference: 2019/012/016/291/010

Premier Dental Products: Multiple affected

21 November 2019

Dental materials

MHRA reference: 2019/011/028/487/001

Randox Laboratories: RX Daytona +

17 December 2019

IVDs, clinical chemistry

Model: RX4040; RX4041

MHRA reference: 2019/012/017/601/001

ShengGuang Medical Instrument (Matz Medical): 1ml INSULIN SYRINGE WITH 21g NEEDLE

15 0ctober 2019

Insulin injection devices

MHRA reference: 2019/010/025/487/019

VitreQ B.V.

16 December 2019

Surgical devices, non-powered

Model: Multiple

MHRA reference: 2019/012/018/291/004

WHILL: WHILL

01 October 2019

Wheelchairs, powered

Model: Model C

MHRA reference: 2019/012/016/291/006

Published 23 December 2019