Field safety notices - 10 to 14 August 2015

List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 August 2015.

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

Arcomed A.G. Medical Systems: Syramed 碌SP6000, Volumed 碌VP7000

19 June 2015

Infusion systems

Model: 6DTO-01, 6T-TO-01, 6T-TO-02, 7DTO-01, 7T-TO-01, 7T-TO-02

MHRA reference:

ArcRoyal: High pressure stopcocks, reference 12-001914, 12-002022, 12-002023, 12-002024

16 July 2015

Infusion and transfusion, connectors

MHRA reference:

Covidien (Medtronic): Puritan Bennett 980 ventilator

31 July 2015

Lung ventilators

MHRA reference:

Philips: Siesta iTS

July 2015

Anaesthetic machines & monitors

MHRA reference:

MicroPort Orthopedics: Profemur庐 neck var/val long CoCr PHAC1254

11 August 2015

Joint prosthesis, hip

MHRA reference:

Reckitt Benckiser Healthcare: Scholl compression hosiery

05 August 2015

Compression garment

MHRA reference:

Salter Labs: Salter Labs NebuTech nebulizer

11 August 2015

Nebulizers

Model: 8960-7

MHRA reference:

Siemens Healthcare Diagnostics: Advia Centaur systems

July 2015

IVDs, clinical chemistry

Ascorbic acid/ascorbic acid diluent lots 54942, 56230, 70673

MHRA reference:

Sunrise Medical Limited: JCM compact bases used with Triton and Neptune seats

FSN JCM CB 01

Supportive seating

MHRA reference:

VYGON: Premicath + stylet + microflash intro

11 August 2015

Vascular cannula and catheters

Model: 1261208

MHRA reference:

Zethon: sterile electrodes

06 July 2015

Surgical, diathermy

MHRA reference:

Updates to this page

Published 14 August 2015