Field safety notices - 23 to 27 November 2015

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2015

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.

See more information on what an FSN is and why it’s important.

Latest FSNs

View the latest FSNs

Baxter Healthcare SA: Cytoluer set

November 2015

Infusion & transfusion, administration sets

Model: GMC7405

MHRA reference: 2015/011/020/051/001

Bayer Consumer Care AG: Contour NEXT control solution

FAO 32B

IVDs, self / home testing

Model: blood glucose meters and/or strips

7335, 3329, 7340, 7336, 7341, 7330, 7336, 7342, 7337, 7331, 7342, 3329, 7340, 7336, 7341, 7330, 7336, 7342, 7337, 7331, 7342

MHRA reference: 2015/011/020/292/017

Baylis Medical: ProTrack™ Microcatheter

Catheter guiding

Model: CIC35-145 and CIC38-145

MHRA reference: 2015/011/023/292/006

Cardica: MicroCutter FG-025320 and FG-025321

MDSS ref MDD15 199

Staples and staple guns

MHRA reference: 2015/011/023/292/017

CNSystems Medizintechnik: Task Force monitor

19 November 2015

Monitors, patient

Model: 3040

MHRA reference: 2015/011/025/292/019

GE Medical Systems LLC: MR Surgical Suite Option

FMI 60885

Magnetic resonance, equipment & accessories

Model: M8074SS, M8053SS, M0074SS

MHRA reference: 2015/011/002/292/022

In2Bones SAS: I.B.S compression screw

17 November 2015

Osteosynthesis, bone screws

Model: S25 ST026, S25 ST014, S25 ST022

MHRA reference: 2015/011/020/051/002

Maquet Cardiopulmonary: Quadrox-iD adult/small adult

19 November 2015

Infusion & transfusion, heart lung circuits

Model: HLS; HIT; PLS

MHRA reference: 2015/011/020/292/009

MeCoBo: Sterile X-ray detectable gauze sponge & non-sterile X-ray detectable gauze sponge

17 November 2015

Basic dressings, absorbents, swabs,

MHRA reference: 2015/011/025/601/005

Medline: Sterile procedure trays

24 November 2015

Surgical devices, non-powered MHRA reference: 2015/011/024/292/009

Molnlycke Health Care: Plastipak syringes

26 October 2015

Injection devices

Model: ProcedurePak®

MHRA reference: 2015/010/027/292/012

Olympus Winter & Ibe: Video telescope

20 November 2015

Endoscopes, rigid

Model: ENDOEYE HD II, 10 mm, 0° and 30° WA50040A (0°), WA50042A (30°)

MHRA reference: 2015/011/017/131/002

Philips Healthcare Nederland B.V: Allura Xper/ Allura Clarity/ Allura Centron/ CV20

PH 3226443

X-ray, fluoroscopy systems

Model: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722022, 722023, 722025, 722026, 722400

MHRA reference: 2015/011/024/292/008

Siemens Healthcare Diagnostics: ADVIA Centaur XPT system

November 2015

IVDs, clinical chemistry

Model: SMN10711433

MHRA reference: 2015/011/025/601/007

Terumo: Terumo® Destination® renal guiding sheath

FSCA 1503

Vascular cannula and catheters

MHRA reference: 2015/011/020/292/018

Thermofisher Scientific: Oxoid antimicrobial susceptibility testing disc penicillin G (P1)

18 November 2015

IVDs, bacteriology

Model: CT0152B

MHRA reference: 2015/011/018/601/006

Updates to this page

Published 30 November 2015