Field Safety Notice - 17 September to 21 September

List of field safety notices (FSNs) from medical device manufacturers from 17 September to 21 September


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

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Abbott: Alinity i Processing Module

14 September 2018

IVDs, clinical chemistry

MHRA reference: 2018/009/019/291/008

Alere Toxicology: Alere DDS2 Test Kit

17 September 2018

IVDs, clinical chemistry

Model: DDS2-403; DDS2-404; DDS2-407; DDS2-412

MHRA reference: 2018/009/013/601/018

CooperSurgical: Lone Star Single-Use Elastic Stays

September 2018

Surgical instruments, minimal access

MHRA reference: 2018/009/017/291/009

Corvia Medical: Inter-atrial Shunt Device (IASD) System II/ Corvia Medical, Inc.

18 September 2018

Vascular cannula and catheters

Model: PN 00261

MHRA reference: 2018/009/019/291/003

Endologix: AFX EndoVascular AAA System

19 September 2018

Implants, non active, endoprostheses

Model: All Models - informative notice - not model specific

MHRA reference: 2018/009/019/601/002

HMC Premedical (Medicina): NasoGastric feeding lube

September 2018

Feeding systems and tubes

Model: NGP8/85 & NGP8/120L & NGP10/120L

MHRA reference: 2018/005/011/401/017

Medtronic: O-arm® 1000 Surgical Imaging System (2nd edition)

September 2018

X Ray, fluoroscopy systems

Model: BI70000027, BI70000027R, BI70000027100, BI70000027100R, BI70000027120, BI70000027120R, BI70000027230, BI70000027230R, BI70000027GER, BI70000027GERR

MHRA reference: 2018/009/020/291/020

Roche: CoaguChek

17 September 2018


MHRA reference: 2018/008/023/291/010

Roche: Elecsys FT4 III

September 2018

IVDs, clinical chemistry

MHRA reference: 2018/009/018/701/016

Siemens Healthcare: ADVIA Chemistry Creatine Kinase Assay

September 2018

IVDs, clinical chemistry

MHRA reference: 2018/009/013/601/013

Stryker: HydroSet Injectable HA Bone Substitute

17 September 2018

Implant materials, bone substitutes

MHRA reference: 2018/009/014/701/007

Thermo Fisher Scientific: Oxoid Bacillus Cereus Selective Medium (PEMBA)

14 September 2018

IVDs, bacteriology

MHRA reference: 2018/009/019/601/007

Published 24 September 2018