Field Safety Notice - 14 to 18 August 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 August 2017
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
Abbott: Alinity hq Analyzer
02 August 2017
IVDs, haematology
MHRA reference: 2017/008/003/701/018
Baxter: HomeChoice Pro; Homechoice Claria APD Cycler
01 August 2017
Dialysis, peritoneal
Model: 5C8310; 5C8310R; 5C4474; R5C8320; 5C6M00; 5C6M10
MHRA reference: 2017/007/027/291/006
Bayer: Essure
16 August 2017
Implants, non active, contraceptive implants
Model: ESS305
MHRA reference: 2017/008/017/121/008
Biomet: Various kits (see recall notice for details)
11 July 2017
Implants, reconstructive, body contouring
Model: Anticoagulant Citrate Dextrose Solution
MHRA reference: 2016/007/022/701/012
CareFusion: Alaris System PC Unit
12 July 2017
Infusion systems
Model: Alaris System PC Unit 8015
MHRA reference: 2017/008/017/121/011
Covidien (Medtronic): Emprint Percutaneous Ablation Antenna
14 August 2017
Therapy tissue ablation
Model: Emprint Percutaneous Ablation Antenna
MHRA reference: 2017/008/015/131/006
Depuy Synthes: LCP Drill Sleeve 1.5 f/Drill Bit ø1.1mm
07 August 2017
Orthopaedic surgical instruments - cutting tools
Model: LCP Drill Sleeve 1.5 f/Drill Bit ø1.1mm; 03.114.001
MHRA reference: 2017/008/014/071/001
Intersurgical
16 August 2017
Breathing system components
Model: 22mm Flextube transport breathing system with non re-breathing valve, for use with Oxylog® 1000, Pneupac® paraPAC®, ventiPAC® and transPAC™, 1.2m
MHRA reference: 2017/008/011/071/005
Isansys LifeCare: Isansys Patient Gateway
14 August 2017
Monitors, patient
Model: Samsung Galaxy Tab S (SM-T800 and SM-T805)
MHRA reference: 2017/008/015/601/001
Leonhard Lang: Defibrillationselektrode SKINTACT DF59N und DF59NC
7 August 2017
Defibrillators, non implantable
Model: DF59N und DF59NC
MHRA reference: 2017/008/009/701/005
Microline Surgical: ReNew Reusable Laparoscopic Instrument Tips
13 July 2017
Surgical instruments, minimal access
Model: Same as Catalogue numbers
MHRA reference: 2017/008/004/701/006
Rocialle: Hip Replacement Pack - Hinchingbrooke
2017/007/004/401/002
Basic dressings, absorbents, swabs, procedure packs
Model: Hip Replacement Pack - Hinchingbrooke
MHRA reference: 2017/007/024/291/013
Stanmore: Custom Implant – Extra Small Metal Casing
9 August 2017
Joint prosthesis, knee
Model: PIN Number 17532
MHRA reference: 2017/008/009/701/010
Stryker: AXS Offset Delivery Assist Catheter
August 2017
Vascular cannula/catheter accessories
Model: AXS Offset Delivery Assist Catheter
MHRA reference: 2017/008/016/071/006
Last updated 30 August 2017 + show all updates
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Correct link added to FSN document for Microline Surgical 2017/008/004/701/006
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First published.