Field Safety Notices - 29 March to 02 April 2021
List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 April 2021.
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
View FSNs since November 2014. FSNs before this date are on the National Archives website
B.Braun: Unimax
22 March 2021
Surgical instruments, minimal access
Model: EJ022SU EJ023SU EJ024SU PG032SU PG033SU PG038R PG042SU PG043SU
MHRA reference: 2021/003/025/601/005
Beckman Coulter: Access Progesterone DE Calibrators
25 March 2021
IVDs, clinical chemistry
Model: Not applicable
MHRA reference: 2021/003/025/601/007
CU Medical Systems: iPAD SP1 Automated External Defibrillator
28 January 2021
Defibrillators, non implantable
Model: iPAD SP1
MHRA reference: 2021/002/001/601/002
Ems Biomedical: Unique EEG
01 July 2019
Monitors, patient
Model: Unique EEG
MHRA reference: 2019/012/016/401/001
Johnson Test Papers: pH Indicator Strips pH 0-6.0
15 March 2021
IVDs, clinical chemistry
Model: 103.3CE
MHRA reference: 2021/003/019/601/007
Medline: Ophthalmic Sterile Procedure Trays including BBraun Syringes
03 March 2021
Injection devices
Model: lnjekt Luer Solo lnjekt Luer Lock Solo lnjekt Luer Duo lnjekt-F Luer Solo lnjekt-F Luer Duo lnjekt-H Luer Solo lnjekt-H Luer Duo Omnifix-F Luer Duo Omnifix-F Luer Lock Solo Omnifix-F Luer Solo Omnifix-H Luer Solo Omnifix Luer Duo Omnifix Luer Lock Duo Omnifix Luer Lock Solo Omnifix Luer Solo The BBraun items included in the Medline Sterile Procedure Trays (SPT) are: 8502340 Omnifix L/S 8508462 Omnifix L/L 4616022F Omnifix L/S 4617053F Omnifix L/L 9161406F Omnifix L/S 9202528 lnjekt L/S 9202625 lnjekt L/S 9202900 lnjekt L/S
MHRA reference: 2021/003/029/291/001
Medtronic: Intellis Recharger
March 2021
Implantable neuro stimulators
Model: 97755
MHRA reference: 2021/003/026/487/007
Omnia: Soft Tissue Punch
25 March 2021
Surgical instruments, articulated cutting
Model: Soft Tissue Punch
MHRA reference: 2021/003/030/487/012
Radiometer: ABL90 FLEX analyzer, ABL90 FLEX PLUS analyzer
FAN 915-416
IVDs, Eetra laboratory testing
Model: 393-090, 393-092
MHRA reference: 2021/004/001/291/001
RECIPE: ClinCal Whole Blood Calibrator Immunosuppressants
22 January 2021
IVDs, clinical chemistry
Model: ClinCal® Whole Blood Calibrator Immunosuppressants
MHRA reference: 2021/003/026/487/008
Roche: cobas SARS-CoV-2 & Influenza A/B Test
17 March 2021
IVDs, viral microbiology
Model: cobas® SARS-CoV-2 & Influenza A/B Test
MHRA reference: 2021/003/023/487/005
Roche: Elecsys Troponin I / Troponin I STAT:
March 2021/FSN-RDS-CoreLab-2021-002
IVDs, clinical chemistry
Model: Elecsys Troponin I / Troponin I STAT:
MHRA reference: 2021/003/026/487/003
SOMATEX: Biopsy Handy and Puncture Sheath
25 March 2021
Surgical instruments, minimal access
Model: Biopsy Handy: 900118, 900126, 900128, 900130, 900134, 900136, 900144
Puncture Sheath: 170257, 170259, 170261, 170269
MHRA reference: 2021/003/029/291/002
Uman Diagnostics: NF-light ELISA
01 March 2021
IVDs, clinical chemistry
Model: 10-7001
MHRA reference: 2021/003/008/601/001