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


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


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


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

Published 21 August 2017
Last updated 30 August 2017 + show all updates
  1. Correct link added to FSN document for Microline Surgical 2017/008/004/701/006
  2. First published.