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
Abingdon Health: Seralite - FLC Serum
09 May 2019
IVDs, immunology SKL0025, lot numbers SS180301 and SS180401
MHRA reference:
B Braun: Connection Lead SP (12V)
10 June 2019
Infusion Systems 8713231
MHRA reference:
Biomet (Zimmer): Biolox Hip Option Taper Adapter
11 June 2019
Joint prosthesis, hip
MHRA reference:
Cook Medical: Advance庐 Enforcer鈩�
24 May 2019
Vascular cannula and catheters Advance庐 Enforcer鈩�
MHRA reference:
Horiba: HORIBA
03 June 2019
IVDs, haematology Yumizen H2500 Yumizen H1500
MHRA reference:
Maquet - Getinge: CB-1000 AXIUS Blower Mister
07 June 2019
Surgical equipment, miscellaneous
MHRA reference:
Occlutech: Occlutech Delivery Set
11 June 2019
Implants, non-active, cardiovascular heart valves
MHRA reference:
Phadia (ThermoFisher): EliA RF IgM (well)
13 May 20109
IVDs, immunology 14-5600-01
MHRA reference:
Philips: BrightView, BrightView X, BrightView XCT
04 June 2019
SPECT-CT
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882478 鈥� BrightView, 882480 鈥� BrightView X
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882482 鈥� BrightView XCT, 882454 鈥� BrightView X upgrade to XCT
MHRA reference:
Randox Laboratories: Assayed Bovine Multi-Sera - Level 1
07 June 2019
IVDs, clinical chemistry AL1027
MHRA reference:
Randox Laboratories: RX Daytona + and RX Imola
10 June 2019
IVDs, clinical chemistry
MHRA reference:
Roche: Accessories
06 June 2019
IVDs, viral microbiology
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cobas庐 6800 System, Model No. 05524245001
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cobas庐 8800 System, Model No. 05412722001
MHRA reference:
St. Jude Medical (Abbot): Nanostim Leadless Cardiac Pacemaker (LCP) system
12 June 2019
Implants, active, intracardiac (leadless)
MHRA reference:
Teleflex: Hudson RCI Air Cushion Face Mask
12 June 2019
Anaesthetic & breathing, masks
MHRA reference: