Field Safety Notices: 26 to 30 April 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 26 April to 30 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Bausch & Lomb: Artelac Rebalance
23 April 2021
Eye lubricant
MHRA reference: 2021/004/023/487/007
BEAVER-VISITEC
20 April 2021
Ophthalmic procedure pack
Model: Anterior Chamber Cannula [Rycroft]
MHRA reference: 2021/004/020/121/001
DB Orthodontics: Double Ended Ligature Tucker
15 April 2021
Pliars (dental)
Model: DB05-0311
MHRA reference: 2021/004/023/701/025
B.Braun: HISTOACRYL BLUE & Transparent 0.5ml/ LAPFIX / PROSET OFX
27 April 2021
Adhesive control devices
Models: 1050044, 1050052, 1050060, 1050071
MHRA reference:2021/003/009/601/001
The above Field Safety Notice (FSN) is an update to the previous FSNs dated 8 March 2021 & 15 March 2021 which include different models and batch numbers.
Please note the FSN dated 15 March originally contained a typographical error referring to an FSN of 3 March. This has been amended by the manufacturer and now correctly refers to the FSN dated 8th March.
Medisoft: Ophthalmology
21 April 2021
Software as a medical device
MHRA reference: 2021/004/022/601/506
Medtronic: Covidien DAR
April 2021
Circuit breathing
MHRA reference: 2021/004/029/291/001
Mercian Surgical Supply
30 March 2021
Burrs
Model: SB0570-50 Sterile Bud Trimmer Burs 70mm x 5mm SB0570-60 Sterile Bud Trimmer Burs 70mm x 6mm
MHRA reference: 2021/003/031/291/003
Ortho Clinical Diagnostics: VITROS 250 & 350 Chemistry Systems
26 April 2021
Instrumentation/platform
Model: 8132086, 1758143, 6801759, 6802153
MHRA reference: 2021/004/029/601/033
P3 Medical
28 April 2021
Proctoscope
Model: Sapimed Rectoscopes and Proctoscopes
MHRA reference: 2021/004/028/601/027
Philips: Efficia DFM 100
08 September 2020
External defibrillator
Model: 866199
MHRA reference: 2021/004/028/487/007
Zhejiang Orient Gene Biotech: Coronavirus Ag Rapid Test Cassette(Swab)
09 March 2021
Sampling device
Model: GCCOV-502a
MHRA reference: 2021/002/016/601/004