Field Safety Notice - 02 to 06 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 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
BioMérieux: NucliSENS® Lysis Buffer
29 September 2017
IVDs, viral microbiology
MHRA reference: 2017/010/003/291/022
Brightwake Limited: Hemosep
23 February 2017
Infusion & transfusion, autologous
Model: CR4336
MHRA reference: 2017/002/022/601/001
Illumina: MiSeqDx Instrument
05 October 2017
IVD, genetic testing
Model: 15036706
MHRA reference: 2017/010/006/701/021
Intelerad Medical Systems
28 September 2017
Picture archiving and communication system (PACS)
Model: IntelePACS
MHRA reference: 2017/010/003/291/018
INTRINSYK MEDICAL DEVICES
18 April 2017
Storage & collection devices
Model: Microdot Safety Lancet 28G Lite
MHRA reference: 2017/008/017/601/017
Maquet: SERVO-air
18 August 2017
Lung ventilators
Model: SERVO-air 6882000
MHRA reference: 2017/008/023/291/010
Merit Medical: Peritoneal Dialysis Catheter Introduction Set
25 September 2017
Dialysis, peritoneal
Model: Infant Flex-Neck® Peritoneal Dialysis catheter
MHRA reference: 2017/010/003/291/016
Thermo Fisher: Thermo Scientific Remel Vibrio Cholerae Inaba agglutinating serum
04 October 2017
IVDs, bacteriology
Model: R30165101
MHRA reference: 2017/010/00
Vascutek: Anaconda™ ONE-LOK™ AAA Stent Graft System
28 September 2017
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference:[2017/009/027/701/023