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