Field Safety Notice - 11 to 15 December 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 December 2017.


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

Agilent: Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2

25 October 2017

IVDs, Cytopathology & Histopathology

MHRA reference: 2017/012/006/291018

Apollo Endosurgery: Lap-Band Adjustable Gastric Banding System

December 2917

Lap-Band adjustable gastric banding system

Model: C-20360

MHRA reference: 2017/012/011/601/008

Beckman Coulter: AQUIOS CL Flow Cytometer System

12 December 2017

IVDs, haematology

MHRA reference: 2017/010/009/601/003

Implantcast GmbH: Trochanter Plate for MUTARS® Proximal Femur Rev

30 November 2017

Osteosynthesis, bone plates

Model: 57101305; 57101305S; 57101307; 57101307S

MHRA reference: 2017/012/001/291/020

Medtronic: NIM-ECLIPSE® System

December 2017

Monitors, patient

Model: NIM Eclipse® System: NWCPUE4, NCCPUE4, NCCPU, NWCPU Single-use Stimulator Probes BNP2001, BNP2002, CNP2001, CNP2002, FTP1001, MNP1001, PSP1000, PSP1001, PSP1002, FTP2001, MNP2001, PSP2000, PSP2001, PSP2002

MHRA reference: 2017/012/008/291/016

Performance Health: Patterson Walking Frame Wheeled Narrow Medium

13 December 2017

Walking aids, walking frames

MHRA reference: 2017/011/008/401/013

Vascutek: Sealed/unsealed Polyester & ePTFE Vascular Grafts

30 November 2017

Implants, non active, surgical vascular grafts & patches

MHRA reference: 2017/012/008/291/009

Vygon GmbH: Premicath/Premistar

13 December 2017

Vascular cannula and catheters

Model: 001261153, 001261203, 001261205, 001261207, 001261208, 001261306, 006261203, VWJ006261203

MHRA reference: 2017/012/013/601/004

Published 18 December 2017