Field Safety Notice: 5 to 9 August 2019

List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 August 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.

Allergan: Allergan Textured Breast Implants and Tissue Expanders

29 July 2019

Implants, breast

MHRA reference: 2018/012/019/291/006

Ecolab: Intraoperative Probe Cover with Long Surgi-Tip

18 July 2019

Ultrasound, imaging

MHRA reference: 2019/007/016/487/008

Eurosets: TRILLY Oxygenator

02 August 2019

Infusion & transfusion, heart lung circuits

EU5057 CONVENIENCE KIT TRILLY STERILE

MHRA reference: 2019/008/008/487/028

ICU: Plum and Sapphire sets

05 August 2019

Infusion & transfusion, administration sets

MHRA reference: 2019/008/005/701/016

Intersurgical: Economy, Anaesthetic Face Masks, Sizes 3, 4, 5 and 6, Adult,

07 August 2019

Anaesthetic & breathing, masks

MHRA reference: 2019/007/010/228/003

Maquet -Getinge: Heater Unit HU 35

01 August 2019

Blood/fluid warming systems

70107.2162; 70107.2163

MHRA reference: 2019/008/005/291/007

Natus-Otometrics: Snap Leadwire & Gold Cup electrodes

August 2019

Stimulators diagnostic

MHRA reference: 2019/008/001/291/002

Natus: Surface temperature probe 268-411800

V40894

Diagnostic measurement and monitoring

MHRA reference: 2019/007/029/487/009

Nobel Biocare: Six titanium abutments,

07 August 2019

Implants, dental

MHRA reference: 2019/007/031/701/004

PerkinElmer: DELFIA/AutoDELFIA PlGF kit, DELFIA/AutoDELFIA PlGF

07 August 2019

IVDs, clinical chemistry

B055-201 (DELFIA/AutoDELFIA PLGF kit), B055-301 (DELFIA/AutoDELFIA PlGF 1-2-3)

MHRA reference: 2019/008/007/701/016

Quantel Medical: easyret

24 July 2019

Therapy, lasers

PABX

MHRA reference: 2019/008/007/291/005

Rocket Medical: Fetal Blood Sampling kit

29 July 2019

Storage & collection devices

R57024-00-SW

MHRA reference: 2019/008/005/601/005

Rocket Medical: R57405

30 July 2019

Urinary catheters and accessories

MHRA reference: 2019/008/005/601/003

Teleflex: Sheridan

06 August 2019

Airway devices

MHRA reference: 2019/005/030/487/001

Thermo Fisher: Oxoid

1 August 2019

IVDs, bacteriology

DR0850M

MHRA reference: 2019/008/002/601/010

Updates to this page

Published 12 August 2019