Field Safety Notice: 10 to 14 June 2019
List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 June 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
Abingdon Health: Seralite - FLC Serum
09 May 2019
IVDs, immunology SKL0025, lot numbers SS180301 and SS180401
MHRA reference: 2019/005/020/601/005
B Braun: Connection Lead SP (12V)
10 June 2019
Infusion Systems 8713231
MHRA reference: 2019/006/012/601/001
Biomet (Zimmer): Biolox Hip Option Taper Adapter
11 June 2019
Joint prosthesis, hip
MHRA reference: 2019/006/011/487/011
Cook Medical: Advance® Enforcer™
24 May 2019
Vascular cannula and catheters Advance® Enforcer™
MHRA reference: 2019/006/010/701/017
Horiba: HORIBA
03 June 2019
IVDs, haematology Yumizen H2500 Yumizen H1500
MHRA reference: 2019/006/007/601/005
Maquet - Getinge: CB-1000 AXIUS Blower Mister
07 June 2019
Surgical equipment, miscellaneous
MHRA reference: 2019/001/028/487/012
Occlutech: Occlutech Delivery Set
11 June 2019
Implants, non-active, cardiovascular heart valves
MHRA reference: 2019/006/012/487/011
Phadia (ThermoFisher): EliA RF IgM (well)
13 May 20109
IVDs, immunology 14-5600-01
MHRA reference: 2019/005/016/601/006
Philips: BrightView, BrightView X, BrightView XCT
04 June 2019
SPECT-CT
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882478 – BrightView, 882480 – BrightView X
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882482 – BrightView XCT, 882454 – BrightView X upgrade to XCT
MHRA reference: 2019/006/011/291/007
Randox Laboratories: Assayed Bovine Multi-Sera - Level 1
07 June 2019
IVDs, clinical chemistry AL1027
MHRA reference: 2019/006/007/601/004
Randox Laboratories: RX Daytona + and RX Imola
10 June 2019
IVDs, clinical chemistry
MHRA reference: 2019/006/011/601/003
Roche: Accessories
06 June 2019
IVDs, viral microbiology
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cobas® 6800 System, Model No. 05524245001
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cobas® 8800 System, Model No. 05412722001
MHRA reference: 2019/006/009/701/004
St. Jude Medical (Abbot): Nanostim Leadless Cardiac Pacemaker (LCP) system
12 June 2019
Implants, active, intracardiac (leadless)
MHRA reference: 2016/010/027/291/016
Teleflex: Hudson RCI Air Cushion Face Mask
12 June 2019
Anaesthetic & breathing, masks
MHRA reference: 2019/006/013/701/017