Field Safety Notice: 14 October to 18 October
List of field safety notices (FSNs) from medical device manufacturers from 14 October to 18 October
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
AVANOS medical: MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit
04 October 2019
Feeding systems and tubes
MHRA reference:
Baylis Medical: TorFlex Transseptal Guiding Sheath
07 October 2019
Vascular cannula/catheter accessories
MHRA reference:
Convatec
02 October 2019
Wound drains
MHRA reference:
Ecolab: Absorbent table covers
10 October 2019
Operating table
Model: NGATC4090N-EU
MHRA reference:
Fast Track Diagnostics: FTD Hepatitis E RNA
FA-2019-14 IVDs, viral microbiology
MHRA reference:
Flexicare Medical: BriteBlade Pro Single Use Fibre Optic Blade & BritePro Solo Single Use Fibre Optic Laryngoscope
18 October 2019
Airway devices
MHRA reference:
Hyphen BioMed: BIOPHEN Normal Control Plasma
17 September 2019
Coagulation
Model: 223201
MHRA reference:
Invacare: Invacare Birdy EVO hoist
16 October 2019
Hoists and slings
MHRA reference:
Medivators (Cantel): ENDO SMARTCAP Tubing
11 October 2019
Endoscopes, flexible
MHRA reference:
Medtronic: SynchroMed庐 II Implantable Infusion Pump
October 2019
Implants, active, infusion pumps
Model: 8637-20,8637-40
MHRA reference:
Merit Medical: DTX Safedraw庐 Kits and Meritrans DTXPlus庐 Devices
1721504-09/20/19-004R
Infusion & transfusion, administration sets
MHRA reference:
Mizuho: Lev贸 Arm
11 October 2019
Operating table
Model: 7887-050
MHRA reference:
NxStage Medical
10 October 2019
Dialysis, haemodialysis
Model: NX1000-3
MHRA reference:
Olea Medical: Olea Sphere
18 April 2019
Computed tomography
MHRA reference:
Omni-Pac Ekco: MediBowl, MediDuo
25 July 2019
Surgical devices, non-powered
MHRA reference:
Origen Biomedical: CryoStore Accessories, O-Wrap, TissueVault
29 August 2019
Infusion & transfusion, blood bags
Model: CBS, SC-1, OW 2436, OW1330, OW1430, OW1430T, TV0909, TV0918, TV1430, TV1950
MHRA reference:
Pega Medical: Scfe Driver Knob Subassy
CPA429
Orthopaedic surgical instruments - insertion/extraction tools
SCF-KNB265 / SCF-KNB273 / SCF-KNB365 / SCF-KNB373
MHRA reference:
Steripack SA: Syringe NaCl 0,9% Luer Lock 10 ml (5ml fill) Steri
08 October 2019
Vascular cannula/catheter accessories
Model: 14366SNS
MHRA reference:
皇冠体育app Binding Site: Optilite Rheumatoid Factor kit
9 October 2019
IVDs, immunology
LK151.OPT
MHRA reference:
皇冠体育apprmo Fisher Scientific: Oxoid
15 October 2019
IVDs, bacteriology
Model: MA0120D/F
MHRA reference: