Field Safety Notices: 25 to 29 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 October 2021
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott Medical: HeartMate Touch Communication System
22 October 2021
Implantable ventricular assist devices
MHRA reference: 2021/010/022/291/005
B Braun Surgical: MONOPLUS and MONOMEND MAX USP 4/0
25 October 2021
Sutures
MHRA reference: 2021/010/026/601/500
Bluetree Group: Obisk Disposable Type IIR Surgical Masks
26 October 2021
Surgical drapes, gowns, masks
Model: OB11R/OB11RT
MHRA reference: 2021/010/022/291/002
Boston Scientific: Hurricane RX Biliary Balloon Dilatation Catheter
21 October 2021
Surgical instruments, minimal access
MHRA reference: 2021/010/022/291/001
CareDx: Olerup QTYPE 11
22 October 2021
IVDs, Immunology
MHRA reference: 2021/010/025/487/015
Euroteknika: Naturall+
18 October 2021
Implants, dental
Model: NICP_35.120
MHRA reference: 2021/010/020/701/048
GE Healthcare: Revolution CT
| GEHC Ref# 25500 | | — |
Computed Tomography
MHRA reference: 2021/010/022/291/003
Atrium Medical (Getinge): Atrium Ocean Water Seal Chest Drain
22 October 2021
Chest Drains and accessories
MHRA reference: 2021/010/025/487/016
IMS EURO: El Dawlia ico Med - Sterile Hypodermic Syringe with Combined Safety Needle
22 October 2021
COVID vaccine delivery device
Model: XT
MHRA reference: 2021/010/021/291/001
Medline: Surgical Gowns
15 October 2021
Surgical drapes, gowns, masks
MHRA reference: 2021/010/021/291/004
Medtronic Ltd: Endurant II/IIs Stent Graft System
October 2021
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference: 2021/010/022/291/006
Ossur: Miami J Select
October 2021
Osteosynthesis, collar
Model: MJS-101, MJSR-101
MHRA reference: 2021/010/026/601/001
Philips Health Systems: CombiDiagnost R90/ProxiDiagnost N90
October 2021
X Ray, fluoroscopy systems
Model: 709030; 709031; 706100
MHRA reference: 2021/010/022/291/004
Smith & Nephew: EVOS 3.5MM X 75MM LCK SCR S-T/ EVOS 3.5MM X 70MM
27 October 2021
Osteosynthesis, bone screws
MHRA reference: 2021/010/027/579/014
Trinity Biotech: HbA1c Controls Kit Level I
05 October 2021
IVDs, clinical chemistry
MHRA reference: 2021/010/025/487/017