Field Safety Notice: 06 to 10 January 2020

List of field safety notices (FSNs) from medical device manufacturers from 06 to 10 January 2020.

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

Depuy Synthes: SPECIALIST® 2 DISTAL FEMORAL CUTTING BLOCK

03 January 2020

Orthopaedic Surgical instruments - Measuring tools

MHRA reference: 2020/001/002/228/017

Eurogine: FSN 21022018

25 September 2019

Implants, non active, contraceptive implants

Model: Ref. 01030000 ANCORA 375 Cu Normal

Ref. 01030400 ANCORA 375 Ag Normal

Ref. 01030200 ANCORA 250 Cu Mini

Ref. 01010500 NOVAPLUS® T 380 Ag Normal

Ref. 01010600 NOVAPLUS® T 380 Ag Mini

Ref. 01010700 NOVAPLUS® T 380 Ag Maxi

Ref. 01020100 NOVAPLUS® T 380 Cu Normal

Ref. 01020200 NOVAPLUS® T 380 Cu Mini

Ref. 01040000 GOLD T® Maxi

Ref. 01040100 GOLD T® Normal

Ref. 01040200 GOLD T® Mini

MHRA reference: 2020/001/009/291/003

GE Healthcare: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation and Giraffe OmniBed Carestation

GEHC Ref 32070-2

Infant incubators

MHRA reference: 2020/001/003/228/004

Karl Storz: Surgical Equipment, Minimal Access

23 December 2019

Surgical equipment, minimal access

Model: 030247-10 W-027318

030247-10 W-027622

030247-10 W-029299

030247-10 W-028852

030247-10 W-029546

031123-10 W-029606

031200-03 W-028530

031200-03 W-028538

031200-03 W-029601

031200-03 W-029596

031200-10 W-027781

031200-10 W-029053

031200-10 W-028738

031200-10 W-029058

031200-10 W-028726

031200-10 W-028592

031200-10 W-028702

031200-10 W-029048

031200-10 W-029561

031200-10 W-029536

031200-10 W-029427

031222-10 W-027713

031222-10 W-027720

031222-10 W-027808

031222-10 W-028719

031222-10 W-028611

031222-10 W-027786

031222-10 W-028120

031222-10 W-028707

031222-10 W-029273

031222-10 W-029280

031322-10 W-027197

031322-10 W-028171

031322-10 W-027939

031322-10 W-028207

031322-10 W-029039

031322-10 W-029437

031322-10 W-029442

031322-10 W-029531

031322-10 W-029541

031322-10 W-029566

031432-10 W-029261

031432-10 W-028543

031432-10 W-029432

031532-10 W-026437

031532-10 W-026871

031532-10 W-027332

031532-10 W-028922

031532-10 W-028928

031532-10 W-028940

031532-10 W-028934

031622-10 W-029555

MHRA reference: 2020/001/003/228/001

Kehler Straße 31(Getinge): QUADROX-iD Pediatric with BIOLINE Coating

24 October 2019

Infusion & transfusion, heart lung circuits

Model: 70104.7041, 70105.0330

MHRA reference: 2019/010/028/487/020

LifeFitness (SciFit): SCIFIT Treadmills

04 July 2017

Diagnostic measurement and monitoring

Model: Scifit CEMed AC5000 TM 220V

MHRA reference: 2019/012/020/601/003

Medicina Ltd: Medicina Oral Enteral and ENFit Syringes

10 October 2019

Feeding systems and tubes

Model: OT01, LHE01LD, LHE01

MHRA reference: 2019/010/010/601/004

Nipro Medical: Vacumed® BLOOD COLLECTION SET

10 December 2019

Storage & collection devices

MHRA reference: 2019/012/019/291/002

Peters Surgical (MNE/19-194): SINGLE USE MONOPOLAR CABLE

08 January 2020

Surgical, diathermy

MHRA reference: 2020/001/009/291/001

Peters Surgical (MNE/19-191): SINGLE USE MONOPOLAR SCISSORS - IN CUT

08 January 2020

Surgical, diathermy

MHRA reference: 2020/001/009/291/002

Siemens Healthcare: Atellica IM & ADVIA Centaur

December 2019

IVDs, clinical chemistry

MHRA reference: 2019/012/023/601/005

Thermo Fisher Scientific Microbiology: Oxoid

30 December 2019

IVDs, bacteriology

Model: PB0298A

MHRA reference: 2019/012/031/601/002

W.L. Gore & Associates: GORE® EXCLUDER® AAA Endoprosthesis & GORE IBE

January 2020

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2019/012/019/291/003

Updates to this page

Published 14 January 2020