Field Safety Notices - 23 to 27 March 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 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 FSN
Abbott: Alere Afinion 2, Afinion 2, Alere Afinion AS100
31 March 2020
IVDs, clinical chemistry
MHRA reference: 2020/003/023/291/008
Applied Medical: Epix latis Grasper
March 2020
Surgical instruments, minimal access
Model: C4130; C4140
MHRA reference: 2020/003/025/701/023
Axis-Shield: Alere NT-proBNP Control/Alere NT-proBNP Calibrator
09 March 2020
IVDs, clinical chemistry
Model: FRBNP200 / FQBNP200 and FRBNP300 / FQBNP300
MHRA reference: 2020/003/012/487/018
Baxter Healthcare: AK 98
17 March 2020
Dialysis, haemodialysis
Model: 115248, 115250, 955403, 955404
MHRA reference: 2020/003/020/291/003
Haemonetics: TEG Manager
20 March 2020
IVDs, extra laboratory testing
MHRA reference: 2020/003/025/487/002
MAG & More: PowerMAG
18 October 2019
External brain stimulation
MHRA reference: 2020/003/019/291/005
Molnlycke Health Care
11 March 2020
Surgical devices, non-powered
Model: Various procedure packs
MHRA reference: 2020/003/012/487/015
Natus: Remlogic
March 2020
IVDs, clinical chemistry
Model: 026259
MHRA reference: 2020/003/016/487/008
Peter Brehm: Screw M6 short/long, Allen Key SW5 Ball Head
R-20200217-3
Osteosynthesis, bone screws
Model: 60901-04
MHRA reference: 2020/003/020/291/001
Promedon: VANTRIS VUR Treatment
16 March 2020
Implants, non active, implantable incontinence and prolapse devices
MHRA reference: 2020/003/018/487/001
Smith’s Medical: Pump Kit, CADD SOLIS VIP MDL 2120
18 March 2020
Infusion systems
Model: 21-2120-0105-02L,21-2120-0105-03L,21-2120-0105-06L,21-2120-0105-07L,21-2120-0105-08L,21-2120-0105-12L,21-2120-0105-13L,21-2120-0105-14L,21-2120-0105-15L,21-2120-0105-17L,21-2120-0105-50L 21-2127-0105-02L,21-2127-0105-06L 21-2127-0105-50L
MHRA reference: 2020/003/025/487/001
The Binding Site: Optilite C1 Inactivator Kit
17 March 2020
IVDs, clinical chemistry
MHRA reference: 2020/003/018/601/009
Vascular Solutions (Teleflex Medical): 5540 Langston Dual Lumen Catheter
25 March 2020
Vascular cannula and catheters
MHRA reference: 2020/003/026/487/001
Welch Allyn: (X can be any combination of 0-9)
MOD1299
ECG
Model: 9293-046-XX9293-047-XX9293-017-XX9293-026-XX9293-061-XX9293-033- XX9293-034-XX
MHRA reference: 2020/003/019/487/001