Field Safety Notice - 06 to 10 November 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 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

Boston Scientific: ELUVIA™ Over the Wire Drug-Eluting Vascular Stent System

Innova ™ Over the Wire Self-Expanding Stent System

November 2017

Implants, non active, peripheral vascular

Model: ELUVIA: H74939295601570, H74939295601510, H74939295701570, H74939295701510 Innova: H74939180051870, H74939180052070, H74939180061870, H74939180062070, H74939180071870, H74939180072070, H74939180081870, H74939180082070, H74939181051830, H74939181052030, H74939181061830, H74939181062030, H74939181071830, H74939181072030, H74939181081830, H74939181082030

MHRA reference: 2017/011/008/228/007

Cook Medical: Wills-Oglesby Percutaneous Gastrostomy Set

19 October 2017

Feeding systems and tubes

MHRA reference: 2017/010/030/291/006

DiaSys Diagnostic Systems GmbH: Urea Test Strips

02 November 2017

IVDs, Clinical Chemistry

Model: N/A

MHRA reference: 2017/011/007/701/032

Elekta: Integrity

November 2017

Radiotherapy

MHRA reference: 2017/011/008/228/005

Elekta: Agility 3.2

November 2017

Radiotherapy

Model: Agility with Integrity

MHRA reference: 2017/011/008/228/006

ICU Medical: Hospira MedNet ™ Medication Management Suite

31 October 2017

Standalone diagnostic workstation

Model: 16037-75-01 and 16037-75-02

MHRA reference: 2017/010/019/291/003

Mediplus Ltd.: Silicone 2 Way Foley Catheter Kit, 16Fr

13 October 2017

Urinary catheters and accessories

Model: 5779

MHRA reference: 2017/011/006/701/014

Spiegelberg: External Lumbar Drainage Catheter

15 February 2016

Cerebrospinal fluid drainage, external

Model: External Lumbar Drainage Catheter ELD33.010.02

MHRA reference: 2016/009/008/299/004

Zimmer: Hex Driver, 2.5 mm with GemLock® Retention

19 October 2017

Dental appliances / instruments

MHRA reference: 2017/010/018/291/014

Published 13 November 2017