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.
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
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