Field Safety Notice: 16 to 20 December 2019
List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 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
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Aesculap SZ380R: ENNOVATE MIS ENTFERNUNGSSCHL脺SSEL KURZ
18 December 2019
Orthopaedic surgical instruments - Insertion/extraction tools
Model: SZ380R
MHRA reference:
Aesculap PL730SU: CAIMAN
18 December 2019
Surgical, diathermy
Model: PL730SU
MHRA reference:
Axiom Medical: Axiom Medical - Class lla-sumps, drains, catheters, and accessories for general, plastic, cardiovascular, and thoracic surgery
31 October 2019
Chest drains and accessories
MHRA reference:
Bedfont Scientific: NObreath V2
04 December 2019
Gas vapour analysers
MHRA reference:
Bock: Domiflex Niedrig Classic
14 November 2019
Beds and accessories
Model: 263
MHRA reference:
CME (Becton): T34 TM Ambulatory Syringe Pump
12 December 2019
Infusion systems
MHRA reference:
Covidien (Medtronic): Biosyntm: UM201
December 2019
Sutures
Model: Polysorbtm: CL915; CL914; CL923; CL925; UL203; SL5690; CL461; CL537; CL811; CL815; CL885; CL911; CL953; GL123; GL124; GL228; GL323; GLS322; L1742K; L2752K; SL1625G; SL5679; SL654; UL877; UL878
MHRA reference:
Depuy Synthes: Sterile Tube Packaging
18 December 2019
Osteosynthesis, bone screws
MHRA reference:
Fast Track Diagnostics: Various FTD Products
December 2019
IVDs, bacteriology
MHRA reference:
Fast Track Diagnostics (FA-2019-19): FTD Respiratory pathogens 21
December 2019
IVDs, bacteriology
MHRA reference:
Karl Storz: Autocon
18 December 2019
Surgical, diathermy
Model: UH300, UH300U, UH400, UH400U, UH401, UH401U
MHRA reference:
Medifab: Shuttle Discovery Verve Stroller
20 September 2019
Buggies for disabled people
MHRA reference:
Philips Medical Systems: Azurion system, R1.2.x and R2.0.x
12 December 2019
X Ray, fluoroscopy systems
Model: 722063, 722064, 722065, 722066, 7722067, 722068, 722078, 722079, 722302, 722303, 722136
MHRA reference:
Premier Dental Products: Multiple affected
21 November 2019
Dental materials
MHRA reference:
Randox Laboratories: RX Daytona +
17 December 2019
IVDs, clinical chemistry
Model: RX4040; RX4041
MHRA reference:
ShengGuang Medical Instrument (Matz Medical): 1ml INSULIN SYRINGE WITH 21g NEEDLE
15 0ctober 2019
Insulin injection devices
MHRA reference:
VitreQ B.V.
16 December 2019
Surgical devices, non-powered
Model: Multiple
MHRA reference:
WHILL: WHILL
01 October 2019
Wheelchairs, powered
Model: Model C
MHRA reference: