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 FSNs
AVANOS medical: MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit
04 October 2019
Feeding systems and tubes
MHRA reference: 2019/010/017/487/025
Baylis Medical: TorFlex Transseptal Guiding Sheath
07 October 2019
Vascular cannula/catheter accessories
MHRA reference: 2019/010/016/487/037
Convatec
02 October 2019
Wound drains
MHRA reference: 2019/009/025/701/034
Ecolab: Absorbent table covers
10 October 2019
Operating table
Model: NGATC4090N-EU
MHRA reference: 2019/010/016/487/004
Fast Track Diagnostics: FTD Hepatitis E RNA
FA-2019-14 IVDs, viral microbiology
MHRA reference: 2019/010/011/228/003
Flexicare Medical: BriteBlade Pro Single Use Fibre Optic Blade & BritePro Solo Single Use Fibre Optic Laryngoscope
18 October 2019
Airway devices
MHRA reference: 2019/010/010/701/010
Hyphen BioMed: BIOPHEN Normal Control Plasma
17 September 2019
Coagulation
Model: 223201
MHRA reference: 2019/010/015/601/004
Invacare: Invacare Birdy EVO hoist
16 October 2019
Hoists and slings
MHRA reference: 2019/006/027/487/002
Medivators (Cantel): ENDO SMARTCAP Tubing
11 October 2019
Endoscopes, flexible
MHRA reference: 2019/010/016/701/019
Medtronic: SynchroMed® II Implantable Infusion Pump
October 2019
Implants, active, infusion pumps
Model: 8637-20,8637-40
MHRA reference: 2019/010/011/228/002
Merit Medical: DTX Safedraw® Kits and Meritrans DTXPlus® Devices
1721504-09/20/19-004R
Infusion & transfusion, administration sets
MHRA reference: 2019/010/014/701/002
Mizuho: Levó Arm
11 October 2019
Operating table
Model: 7887-050
MHRA reference: 2019/010/017/701/006
NxStage Medical
10 October 2019
Dialysis, haemodialysis
Model: NX1000-3
MHRA reference: 2017/001/018/401/011
Olea Medical: Olea Sphere
18 April 2019
Computed tomography
MHRA reference: 2019/007/003/487/019
Omni-Pac Ekco: MediBowl, MediDuo
25 July 2019
Surgical devices, non-powered
MHRA reference: 2019/010/011/228/008
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: 2019/010/014/487/024
Pega Medical: Scfe Driver Knob Subassy
CPA429
Orthopaedic surgical instruments - insertion/extraction tools
SCF-KNB265 / SCF-KNB273 / SCF-KNB365 / SCF-KNB373
MHRA reference: 2019/010/008/601/005
Steripack SA: Syringe NaCl 0,9% Luer Lock 10 ml (5ml fill) Steri
08 October 2019
Vascular cannula/catheter accessories
Model: 14366SNS
MHRA reference: 2019/010/015/291/015
The Binding Site: Optilite Rheumatoid Factor kit
9 October 2019
IVDs, immunology
LK151.OPT
MHRA reference: 2019/010/011/601/014
Thermo Fisher Scientific: Oxoid
15 October 2019
IVDs, bacteriology
Model: MA0120D/F
MHRA reference: 2019/010/015/601/005