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 FSNs

ANADOLU TIP TEKNOLOJILERI: FOCUS FORCE Aspheric Intraocular Lens

002/AS60130/17.00

Implants, non active, intraocular

MHRA reference: 2017/001/024/291/016

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: 2017/004/010/299/025

Bard: MR GHIATAS® Beaded Breast Localization Wire

FA2017-10

Surgical devices, non-powered

MHRA reference: 2017/004/005/601/006

Medicina: 5ml Luer Lock IV Syringe

03 April 2017

Injection devices

Model: IVL05

MHRA reference: 2017/004/004/601/003

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

February 2017

Surgical equipment, miscellaneous

MHRA reference: 2017/003/001/291/003

Phagenesis: Phagenyx

April 2017

Therapy, electrotherapy

Model: EPSA

MHRA reference: 2017/004/010/701/023

Siemens: RAPID Point ®500 Blood Gas Analyzer

April 2017

IVDs, extra laboratory testing

MHRA reference: 2017/004/010/601/007

Smirthwaite: Bath Chair

05 April 2017

Bath and aids

Model: 7607

MHRA reference: 2017/004/006/601/003

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

11 April 2017

Implants, active, defibrillators

Model: See FSN

MHRA reference: 2017/004/010/299/006

Taizhou Xinkang Medical Materials: Wound Dressing

23 March 2017

Basic dressings, absorbents, swabs

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

MHRA reference: 2017/004/007/299/025

Waters: ACQUITY UPLC Sample Organizer, IVD

10 April 2017

IVDs, clinical chemistry

Model: ACQUITY UPLC Sample Organizer, 186015020IVD

MHRA reference: 2017/004/007/299/018

bioMérieux: ETEST® ETP32 (Ertapenem)

7 April 2017

IVDs, bacteriology

MHRA reference: 2017/004/012/299/006

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