Field Safety Notice - 10 April to 14 April 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 April 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

ANADOLU TIP TEKNOLOJILERI: FOCUS FORCE Aspheric Intraocular Lens

002/AS60130/17.00

Implants, non active, intraocular

MHRA reference:

Arrow International: Arrow Pressure Injectable PICC Kit

10 April 2017

Vascular cannula and catheters

Model: Arrow Pressure Injectable PICC Kit; various makes and models

MHRA reference:

Bard: MR GHIATAS庐 Beaded Breast Localization Wire

FA2017-10

Surgical devices, non-powered

MHRA reference:

Medicina: 5ml Luer Lock IV Syringe

03 April 2017

Injection devices

Model: IVL05

MHRA reference:

M枚ller-Wedel: CU 5001/3 und CU 3-21/23(Pilot run 14 devices)

February 2017

Surgical equipment, miscellaneous

MHRA reference:

Phagenesis: Phagenyx

April 2017

Therapy, electrotherapy

Model: EPSA

MHRA reference:

Siemens: RAPID Point 庐500 Blood Gas Analyzer

April 2017

IVDs, extra laboratory testing

MHRA reference:

Smirthwaite: Bath Chair

05 April 2017

Bath and aids

Model: 7607

MHRA reference:

Sorin Group (LivaNova): Ovatio / Paradym / Paradym 2 / Paradym RF / Intensia devices

11 April 2017

Implants, active, defibrillators

Model: See FSN

MHRA reference:

Taizhou Xinkang Medical Materials: Wound Dressing

23 March 2017

Basic dressings, absorbents, swabs

Model: NO.8, NO.9, NO.3

MHRA reference:

Waters: ACQUITY UPLC Sample Organizer, IVD

10 April 2017

IVDs, clinical chemistry

Model: ACQUITY UPLC Sample Organizer, 186015020IVD

MHRA reference:

bioM茅rieux: ETEST庐 ETP32 (Ertapenem)

7 April 2017

IVDs, bacteriology

MHRA reference:

Updates to this page

Published 18 April 2017