Field Safety Notices: 26 to 30 September 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 September 2022.
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
B Braun Medical: OM760SU SINGLE USE SURGICAL INSTR.
27 September 2022
Surgical Instruments, Minimal Access
MHRA reference: 2022/009/027/601/005
Baxter: Prismaflex HF1000 set, Prismaflex HF1400 set, Prismaflex HF20 set, Prismaflex M100 set, Prismaflex M150 set, Prismaflex M60 set, Prismaflex ST100 set, Prismaflex ST150 set, Prismaflex ST60 set
September 2022
Dialysis, Blood Lines
MHRA reference: 2022/009/023/596/009
CareDx: QTYPE 11
23 September 2022
IVDs, Immunology
MHRA reference: 2022/009/023/701/027
Cooper Surgical: Humidifier Bottle and Syringe filter kit for BT37
12 July 2022
Laboratory Equipment Associated With IVF, Cells, Tissues
MHRA reference: 2022/009/015/599/018
DiaMed: 001500 / 001500RECOND IH-500
23 September 2022
IVDs, Cytopathology & Histopathology
MHRA reference: 2022/009/023/601/502
GE Healthcare: 9100c NXT
Ref 34131
Anaesthetic Machines & Monitors
MHRA reference: 2022/009/023/701/024
Invacare: Action 4NG heavy duty
26 September 2022
Wheelchairs, Manual
MHRA reference: 2022/009/026/701/009
Merit Medical Systems: CorVocet Biopsy System
12 August 2022
Surgical Instruments, Minimal Access
MHRA reference: 2022/008/015/596/004
Siemens Healthcare GmBH: ARTIS pheno
September 2022
X Ray, Fluoroscopy Systems
MHRA reference: 2022/009/021/601/001
Thermo Fisher Scientific: TaqPath™ COVID‑19 HT Kit
21 September 2022
IVDs, SARS-CoV-2 PCR Test
Model: A50883
MHRA reference: 2022/009/027/701/055