Field safety notices - 2 May - 6 May 2016

List of field safety notices (FSNs) from medical device manufacturers from 2 May to 6 May 2016


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 Laboratories: CELL-DYN Emerald Cleaner

3 May 2016

IVDs, haematology

MHRA reference: 2016/005/004/291/014

Alphadent: Ceka-Preciline

4 May 2016

Dental, laboratory equipment

MHRA reference: 2016/005/004/291/011

American Surgical: Delicot

31 March 2016

Basic dressings, absorbents, swabs,

Model: 63-10

MHRA reference: 2016/005/003/601/001

Beckman Coulter

3 May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/003/601/005

BioArray Solution: HEA BeadChip Kit

25 April 2016

IVDs, immunology

MHRA reference: 2016/004/028/299/013

Coloplast: SpeediCath® Compact Eve®, CH 12

3 May 2016

Urinary catheters and accessories MHRA reference: 2016/005/003/291/041

Eckert & Ziegler: Oesophagus Set, also as Bougie Applicators

2 May 2016

Radiotherapy, afterloading

Model: (LAZ24-08), (LAZ24-10), (LAZ24-12)

MHRA reference: 2016/005/005/181/003

Handicare: Eva mobile Iifts

22 March 2016

Hoists and slings

Model: 60100001, 6OI0000IBC, 60100002, 60100003, 60100006, 60100006!, 60100007, 60100009, 60100010. 60100011, 60100012, 601000133, Eva400EU, Eva400BC, Eva4SOEE, Eva600EE, Eva450, Eva45OEE, Eva45OEM LL, Eva45OEE, Eva600EE, Eva400EM, Eva45OEM, Uva45OEM MHRA reference: 2016/005/003/291/033

Immucor: LIFECODES LifeScreen Deluxe (LMX)

22 April 2016

IVDs, immunology MHRA reference: 2016/004/029/291/007

Leica Biosystems: Aperio eSlide Manager

4 April 2016

IVDs, cytopathology & histopathology

MHRA reference: 2016/004/029/291/017

Medtronic: RestoreSensor Multi-Program Rechargable/ Neurostimulator Restore Sensor SureScan MRI

May 2016

Implants, active, stimulators, neuro Model: 37714 and 97714

MHRA reference: 2016/005/004/071/004

NRT: Adora RF

13 April 2016

X Ray, Fluoroscopy Systems

Model: 04350000

MHRA reference: 2016/004/014/601/002

Ortho Clinical Diagnostics: ORTHO VISION™ Max Analyzer for ORTHO BioVue® Cassettes

April 2016

IVDs, blood transfusion

Model: 6904578

MHRA reference: 2016/004/028/601/012

Randox Laboratories: Immunoassy Premium Control Level 3 and Immunoassay Premium Plus Control Tri Level

10 August 2015

IVDs, clinical chemistry

Model: IA2640, IA3112

MHRA reference: 2015/008/014/601/005

Sero: Seronorm

18 April 2016

IVDs, clinical chemistry

MHRA reference: 2016/004/028/701/016

Smiths Medical: CADD® Administration Sets with Flow Stop Free-Flow Protection

4 May 2016

Infusion & transfusion, administration sets MHRA reference: 2016/004/022/299/002

Smith & Nephew: R3 0 Degree XLPE Acetabular Liner 32mm ID X OD 48m

3 May 2016

Joint prosthesis, hip MHRA reference: 2016/005/004/299/009

Synovis Micro Companies Alliance: Flow COUPLER


Implants, non active, surgical vascular grafts & patches

Model: GEM2752-FC, GEM2753-FC, GEM2754-FC, GEM2755-FC, GEM2756-FC MHRA reference: 2016/004/029/291/009

Thermofisher Scientific: Oxoid Microbact Haemolysin Reagent MB1249A

29 April 2016

IVDs, bacteriology

MHRA reference: 2016/005/003/601/004

Tosoh: Automated Enzyme Immunoassay Analyzer AIA-2000 LA

4 May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/004/291/013

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