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
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View . FSNs before this date are on the
Bausch & Lomb: Artelac Rebalance
23 April 2021
Eye lubricant
MHRA reference:
BEAVER-VISITEC
20 April 2021
Ophthalmic procedure pack
Model: Anterior Chamber Cannula [Rycroft]
MHRA reference:
DB Orthodontics: Double Ended Ligature Tucker
15 April 2021
Pliars (dental)
Model: DB05-0311
MHRA reference:
B.Braun: HISTOACRYL BLUE & Transparent 0.5ml/ LAPFIX / PROSET OFX
27 April 2021
Adhesive control devices
Models: 1050044, 1050052, 1050060, 1050071
MHRA reference:
The above Field Safety Notice (FSN) is an update to the previous FSNs dated & 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:
Medtronic: Covidien DAR
April 2021
Circuit breathing
MHRA reference:
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:
Ortho Clinical Diagnostics: VITROS 250 & 350 Chemistry Systems
26 April 2021
Instrumentation/platform
Model: 8132086, 1758143, 6801759, 6802153
MHRA reference:
P3 Medical
28 April 2021
Proctoscope
Model: Sapimed Rectoscopes and Proctoscopes
MHRA reference:
Philips: Efficia DFM 100
08 September 2020
External defibrillator
Model: 866199
MHRA reference:
Zhejiang Orient Gene Biotech: Coronavirus Ag Rapid Test Cassette(Swab)
09 March 2021
Sampling device
Model: GCCOV-502a
MHRA reference: