Field safety notices - 14 March to 18 March 2016
List of field safety notices (FSNs) from medical device manufacturers from 14 March to 18 March 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
Alphatec Spine: Osseofix Sterile Package Implant
11 March 2016
Spinal Implants
Model: 21298-55
MHRA reference: 2016/003/012/601/001
Covidien: Covidien Curity™ All Purpose Gauze Sponges, Curity™ X-Ray Detectable Laparotomy Sponges, Kerlix™ X-Ray Detectable Laparotomy Sponges, Vistec™ X-Ray Detectable Sponges
March 2016
Basic dressings, absorbents, swabs, procedure packs
MHRA reference: 2016/003/011/701/001
Maquet
11 March 2016
Anaesthetic machines & monitors
Model: Flow-i C20 CSA
MHRA reference: 2015/010/030/401/001
Össur: Papoose
Recall 012016
Orthoses
Model: Papoose Infant Immobiliser
MHRA reference: 2016/003/010/292/035
QIAGEN: Disposable Filter-Tips, 300 µl
8 March 2016
IVD, genetic testing
MHRA reference: 2016/003/010/701/019
Roche
SB_RDC_2016_02
Infusion systems
Model: Accu-Chek Insight System
MHRA reference: 2016/003/003/701/016
Sybron: TF Adaptive Gutta Percha Point Size SM3 50pk
ORA1601
Dental appliances / instruments
MHRA reference: 2016/003/010/701/001
Teleflex: Kidney Transplant Catheter, Sterile Pack
16 March 2016
Vascular cannula and catheters
MHRA reference: 2016/003/017/292/001
Zimmer Biomet: Revitan prox. spout and Revitan prox. cylindrical
11 March 2015
Joint prosthesis, hip
MHRA reference: 2016/003/011/292/021