Field Safety Notice - 30 October to 3 November 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 30 October to 3 November 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

Abbott: Alinity hq Analyzer

26 October 2017

IVDs, heamatology

MHRA reference: 2017/010/031/291/015

DePuy International Ltd: Acetabular Cup Introducer

31 October 2017

Orthopaedic surgical instruments - insertion/extraction tools

Model: 962636000

MHRA reference: 2017/010/030/291/005

Draeger: Fabius GS/ GS premium/ MRI/ Plus/ Plus XL/ Tiro

October 2017

Anaesthetic machines & monitors

MHRA reference: 2017/011/001/291/002

Fukuda Densh UK: Dynascope

16 October 2017

Monitors, patient

Model: DS 8100

MHRA reference: 2017/010/027/601/010

GE: Carestation 620, Carestation 650, Carestation 650c

October 2017

Anaesthetic machines & monitors

MHRA reference: 2017/010/025/701/026

HTL-Strefa: Microdot Droplet Pen Needle 4mm x 32G

12 October 2017

Insulin injection devices

Model: Microdot Droplet Pen Needle 4mm x 32G 810

MHRA reference: 2017/010/023/291/010

Johnson & Johnson: 1-DAY ACUVUE® MOIST Brand Contact Lenses

25 October 2017

Contact lenses & shells

MHRA reference: 2017/010/027/291/008

Johnson & Johnson: ACUVUE® OASYS®, ACUVUE® ADVANCE®, ACUVUE MOIST® for Astigmatism

26 October 2017

Contact lenses & shells

MHRA reference: 2017/010/027/291/025

Johnson & Johnson Vision Care, Inc.: ACUVUE® OASYS® for ASTIGMATISM

26 October 2017

Contact Lenses & Shells

Model: N/A

MHRA reference: 2017/010/030/291/001

LivaNova

24 October 2017

Heart lung machines

Model: CP5 CENTRIFUGAL PUMP, 60-00-60

MHRA reference: 2017/010/025/701/023

Maquet: SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Cath

17 October 2017

Cardiac assist pumps

Model: SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK®

MHRA reference: 2017/010/023/291/011

Maquet: Heater Cooler Unit HCU20; Heater Cooler Unit HCU30

26 October 2017

Blood/fluid warming systems

Model: 70101.0892; 70101.0895; 70101.0896; 70102.8717; 70101.7239; 70102.2333; 70102.2336; 70102.8718; 70103.4642; 70103.4653;70103.4371

MHRA reference: 2017/010/030/291/002

Medline

27 October 2017

Surgical equipment, miscellaneous

Model: Soft suction liner 3000cc/ml (with tube / Med-Gel)

MHRA reference: 2017/010/030/291/018

Oculentis BV: LENTIS

27 October 2017

Implants, non active, intraocular

Model: LENTIS - All models starting with L or LS or LU

MHRA reference: 2017/009/013/291/009

Smith & Nephew: Legion HK Tibial Base

October 2017

Joint prosthesis, knee

MHRA reference: 2017/010/031/291/017

Stanmore: METS Principal Shaft

26 October 2017

Joint prosthesis, knee

Model: msfshft/150

MHRA reference: 2017/010/030/291/003

Stryker: Thoracic Pedicle Feeler

16 October 2017

Surgical navigation system

Model: Thoracic Pedicle Feeler

MHRA reference: 2017/010/027/291/020

Stryker: rHead® System Radial Head Arthroplasty / Uni Elbow

October 2017

Joint prosthesis, elbow

MHRA reference: 2017/010/016/701/063

Published 7 November 2017