Field Safety Notices - 06 July to 10 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 06 July to 10 July 2020
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
View a list of FSNs published since January 2020
FSNs before this date are on the National Archives Website
Aesculap (B Braun): S4C CROSS CONNECTOR FIXED 22MM
09 July 2020
Osteosynthesis, bone screws
Model: SW112T
MHRA reference: 2020/007/009/291/010
Boston Scientific: Captivator/Captiflex Single-Use Polypectomy Snare
92556729-FA
Surgical, diathermy
MHRA reference: 2020/007/006/291/004
GE: Carescape One
FMI 36147
Monitors, patient
MHRA reference: 2020/007/008/029/002
Luminex: VERIGENE® Processor SP
15 June 2020
IVDs, bacteriology
MHRA reference: 2020/007/002/701/015
Osang Healthcare: GeneFinder COVID-19PlusRealAmp Kit
19 June 2020
IVDs, SARS-CoV-2 Immunoassay (Serology)
Model: IFMR-45
MHRA reference: 2020/007/008/291/001
Roche: cobas® 6500 urine analyzer series (cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer)
April 2020
IVDs, clinical chemistry
MHRA reference: 2020/004/015/487/010
Roche Diagnostics: Elecsys Anti-CCP
June 2020
IVDs, immunology
MHRA reference: 2019/007/004/701/011
Teleflex: Green Rusch Lite Miller 2 Green Rusch Lite Miller 3 Green Rusch Lite Miller 4 Green Rusch Lite Mac 2 Green Rusch Lite Mac 3 Green Rusch Lite Mac 4 Green Rusch Lite Mac 3.5
09 July 2020
Airway devices
MHRA reference: 2020/007/009/291/009
Teleflex Medical: Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, AC3™ Series IABP System
21 May 2020
Cardiac assist pumps
Model: Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, AC3™ Series IABP System - IAP-0400 IAP-0400E IAP-0500 IAP-0500E IAP-0500I IAP-0500J IAP-0500NL IAP-0535 IAP-0700 IAP-0701
MHRA reference: 2020/007/007/291/002
Tristel Solutions: Tristel Duo ULT
TSLFSN3
Disinfectants for medical devices
Model: TSL022601
MHRA reference: 2020/007/003/601/003