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.


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

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


11 March 2016

Anaesthetic machines & monitors

Model: Flow-i C20 CSA

MHRA reference: 2015/010/030/401/001

Össur: Papoose

Recall 012016


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



Infusion systems

Model: Accu-Chek Insight System

MHRA reference: 2016/003/003/701/016

Sybron: TF Adaptive Gutta Percha Point Size SM3 50pk


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

Published 21 March 2016