Field Safety Notices - 25 February 2019 - 1 March 2019
List of field safety notices (FSNs) from medical device manufacturers from 25 February 2019 - 1 March 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
View the latest FSNs
ArthroCare (Smith & Nephew): SmartStitch PerfectPasser Connecto
26 February 2019
Sutures
MHRA reference: 2019/002/028/487/032
Brainlab: Spine & Trauma 3D Navigation 1.0
11 February 2019
Surgical navigation system and accessories
22268C. the model numbers are listed in Material column on customer list attachment
MHRA reference: 2019/002/025/701/017
Cook: Inferior Vena Cava (IVC) Filter
25 February 2019
Implants, non-active, vena cava filters
MHRA reference: 2019/002/025/291/004
Etac: Molift 2-point Sling Bar- All sizes
26 February 2019
Hoists and slings
430016, 1430017, 1430021, 1830001, 183002, 183002C, 1830003
MHRA reference: 2019/002/028/487/035
Fast Track Diagnostics: FTD Fever and rash
February 2019
IVDs, viral microbiology
MHRA reference: 2019/002/022/701/024
GE: ECG trunk cable
GEHC Ref# 39000
Infusion & transfusion, heart lung circuits
ECG
ECG trunk cable 2106309-001, 2106309-002
MHRA reference: 2019/002/022/701/008
Hamilton: HAMILTON-G5/S1 ventilator unit
11 February 2019
Lung ventilators
MHRA reference: 2019/002/027/291/004
IHSS: SYNTHES CODMAN MATRIX
27 February 2019
Osteosynthesis, bone plates
SYNTHES CODMAN MATRIX
MHRA reference: 2019/002/027/291/020
Luminex: ARIES products, see attached FSN
19 February 2019
IVDs, bacteriology
PN 50-10017, PN 50-10031, PN 50-10037, PN 50-10020, PN
MHRA reference: 2019/002/028/487/026
Luminex: xTAG® Gastrointestinal Pathogen Panel (GPP)
February 2019
IVDs, viral microbiology I032C0324
MHRA reference: 2019/002/020/291/005
Medacta International: GMK UNI Femur Sizes 3 & 4
22 February 2019
Joint prosthesis, knee
MHRA reference: 2019/002/028/487/031
MEIKA Group: Lipocell
01 February 2019
Dermal substitutes, tissue scaffolds
MHRA reference: 2019/002/028/487/030
Ortho-Clinical: VITROS 3600, 5600, XT7600, ECi, ECiQ
February 2019
IVDs, clinical chemistry
MHRA reference: 2019/002/026/601/500
Radiometer: TCM5 FLEX/TCM5 BASIC
FAN 915-375
Diagnostic measurement and monitoring
MHRA reference: 2017/010/012/291/008
Randox Laboratories: Urinalysis Control Level 2
22 February 2019
IVDs, clinical chemistry
Urinalysis Control Level 2 UC5034
MHRA reference: 2019/002/022/601/015
Regen Lab: RegenKit-BCT-3T, RegenKit-BCT-2A, RegenKit-BCT-4
06 February 2019
Storage & collection devices
MHRA reference: 2019/002/011/487/002
TERUMO: LifePearl® microspheres
February 2019
Implants, non-active, embolisation products
8LP2S200
MHRA reference: 2019/002/026/291/011
Vyaire Medical: enFlow
FSCA 19-001
Blood/Fluid Warming Systems
MHRA reference: 2019/001/004/302/001
Last updated 8 March 2019 + show all updates
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Added FSCA for Vyaire Medical: enFlow
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First published.