Field Safety Notice: 23 to 26 April 2019
List of field safety notices (FSNs) from medical device manufacturers from 23 to 26 April 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
Arrow International: Arrow® PICC and JACC kits
24 April 2019
Vascular cannula and catheters
MHRA reference: 2019/004/025/291/003
Axis-Shield: Alere NT-proBNP Control/Alere NT-proBNP Calibrator
077565
IVDs, clinical chemistry
Model: FRBNP200 / FQBNP200 and FRBNP300 / FQBNP300
MHRA reference: 2019/004/025/291/007
Baxter
April 2019
Infusion & transfusion, administration sets
MHRA reference: 2019/004/018/487/009
Biokit S.A.: QUANTIA RF
05 April 2019
IVDs, clinical chemistry
MHRA reference: 2019/004/018/291/007
Boston Scientific: 92358366-FA
24 April 2019
Implants, active, stimulators, neuro
MHRA reference: 2019/004/024/487/014
Endo Tools Therapeutics: TAPES
23 April 2019
Endoscopes, flexible
Model: IA-TAGxDELIxSYS-00
MHRA reference:2019/004/012/601/010
Europlaz Technologies: TIVATEK
25 March 2019
Infusion & transfusion, administration sets
Model: TT303E TT302E TT224ER TT202E
MHRA reference: 2019/003/025/291/016
Invacare: BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM
19 March 2019
Wheelchairs, powered
MHRA reference: 2019/004/002/291/001
Judd Medical
15 April 2019
Surgical, diathermy
MHRA reference: 2019/002/014/487/007
Macopharma: Several references ACDA impacted
12 April 2019
Several references ACDA impacted
MHRA reference: 2019/004/023/291/020
Maquet (Getinge): Volista STANDOP, Volista TRIOP
17 April 2019
Lamps & lights
MHRA reference: 2019/004/024/487/017
Pennine Healthcare: Pennine Healthcare - Prestrol Suction Catheter – FG/CH 12(4.0) 48cm
18 April 2019
Airway suction equipment
MHRA reference: 2019/004/015/601/007
Robinson Healthcare: Instrapac
23 April 2019
Surgical instruments, articulated holding
Model: C03095
MHRA reference: 2019/004/025/601/002