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
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
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
2016
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