Field Safety Notice: 04 to 08 November 2019
List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 November 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
Brainlab: Patient Data Manager (PDM)
08 October 2019
Infusion systems
MHRA reference: 2019/009/030/701/006
Chromsystems Instruments & Chemicals: Multilevel Saliva Calibrator Set and Control
09 September 2019
IVDs, clinical chemistry
Model: 73039, 0349, 0350
MHRA reference: 2019/011/006/291/018
Full Support Healthcare: Easidrape
9 December 2019
Surgical drapes, gowns, masks
Model: 50441
MHRA reference: 2019/011/004/601/001
Gambro (Baxter): Artiset HD DNL HC; Artset pre-post
05 November 2019
Dialysis, blood lines
Model: UK; 955075
MHRA reference: 2019/011/004/487/021
GE Healthcare: ApexPro Telemetry System
GEHC Ref 36140
Monitors, patient
MHRA reference: 2019/011/007/291/001
Haemonetics: Cell saver
30 October 2019
Infusion & transfusion, autologous
Model: 00260-00, 00261-00, 00263-00, 0263A-00, 00265-00, 0260F-00, 00265F-00, CSE-FP-125V, CSE-FP-225V, CSE-FP-225F, CSE-P-125, CSE-P-225
MHRA reference: 2019/011/001/701/025
Maquet - Getinge: Yellow Bin/Blue Bin
28 October 2019
Infusion & transfusion, heart lung circuits
Model: 701035710, 701045404, 701047490, 701052876, 701054573, 701054988, 701063206, 701068444, 701070151, 701071787, 701071787, 701071848, 701071853, 701072827, 701073246
MHRA reference: 2019/010/029/291/006
Medline: Sterile Procedure Trays
25 October 2019
Surgical devices, non-powered
MHRA reference: 2019/010/028/487/009
Medtronic: Passive Biopsy Needle Kit
October 2019
Surgical instruments, minimal access
Model: Passive Biopsy Needle Kit - 9733068, 9731754
MHRA reference: 2019/011/001/487/005
Stryker: Sliding Core UHMPWE
17 October 2019
Joint prosthesis, ankle
MHRA reference: 2019/011/007/701/009
Thermo Fisher Scientific: Remel
06 November 2019
Antimicrobial susceptibility testing
Model: R30954901/ZA01
MHRA reference: 2019/011/006/601/003