Field safety notices - 13 to 17 July 2015

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 July 2015.


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

Atom Scientific Limited: Neutral red 0.5% aqueous, Gram stain kit (neutral red counterstain) (RRSP109, RRSK5)


IVDs, cytopathology & histopathology

MHRA reference: 2015/007/014/291/007

Bio-Rad Medical Diagnostics GmbH: Anti-Jka (JK1)

10 July 2015

IVDs, blood transfusion

Model: 808176

MHRA reference: 2015/007/014/291/015

Cook Medical: Flexor RTPS guiding sheath

08 June 2015

Vascular cannula and catheters

Model: KCFW-10.0-35-RB-RTPS-100

MHRA reference: 2015/007/009/601/016

Cook Medical: Beacon® Tip angiographic catheters

02 July 2015

Vascular cannula and catheters

MHRA reference: 2015/007/013/291/011

DePuy Synthes: ATTUNE® INTUITION™ tibial articulation surface instrument

June 2015

Trial tibial knee insert

MHRA reference: 2015/007/014/291/010

Intuitive Surgical: da Vinci Xi (IS4000) instrument arm drape

03 July 2015

Surgical drapes, gowns, masks

Model: 470015-05, 470015-06

MHRA reference: 2015/007/009/701/017

Invacare: Reliant 350

10 July 2015

Moving & handling

Model: all models

MHRA reference: 2015/007/014/291/018

Medtronic: EnVeo R loading system

July 2015

Implants, non-active, cardiovascular heart valves

Model: LS-ENVEOR-23 and LS-ENVEOR-2629

MHRA reference: 2015/007/016/291/004

Northern Digital: Disposable reflective marker sphere (DRMS)

10 July 2015

Surgical Navigation System

Model: 41773, 41774, 41813

MHRA reference: 2015/006/026/291/015

Ortho Solutions: UltOS 3.5mm locking screw / UltOS 2.7mm locking sc

14 July 2015

Osteosynthesis, bone screws

Model: UltOS

MHRA reference: 2015/007/014/291/006

Philips Healthcare: Allura Xper systems

16 June 2015

X-ray, fluoroscopy systems

Model: 722010, 722011, 722012, 722013, 722022, 722023, 722024 and 722025

MHRA reference: 2015/007/014/291/003

Radiometer: Fixation kit N20

FAN 915-340

Diagnostic measurement and monitoring

MHRA reference: 2015/007/006/291/010

Siemens Healthcare Diagnostics: ADVIA Chemistry acetaminophen reagent

June 2015

IVDs, clinical chemistry

Model: SMN 10327381

MHRA reference: 2015/007/001/601/007

Stryker: SERFAS 900 energy probe (also known as 90R probe)

13 July 2015

Surgical, diathermy

MHRA reference: 2015/007/014/291/005

WallacOy: DELFIA Xpress PIGF kit

09 July 2015

IVDs, clinical chemistry

Model: 6007-001 0, 6007-0020, 6007-002C

MHRA reference: 2015/007/014/291/004

Wilson Instruments (SHA) Co: Single use disposable cleaning brush WS-1523WA(P)DH

Date of FSN / FSN reference (normal style)

Endoscopes, flexible

MHRA reference: 2015/005/021/401/013

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