Field Safety Notice - 12 November to 16 November

List of field safety notices (FSNs) from medical device manufacturers from 12 November to 16 November


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

CIVCO Medical Instruments: L25 Needle Guide Bracket

30 October 2018

Surgical instruments, minimal access

MHRA reference: 2018/011/012/291/005

Canon Medical Systems Corporation: Radrex-i


X ray, general

Model: DRAD-3000E/W8

MHRA reference: 2018/011/001/487/018

Cardinal Health: Protexis Neoprene Surgical Glove

31 October 2018

Gloves, surgical & examination

MHRA reference: 2018/011/014/701/012

Carestream Health: KODAK DirectView DR 7500 System

31 October 2018

X ray, general

MHRA reference: 2018/011/013/701/004

Exactech: Shoulder GPS Reverse Drill Kit; GPS Hex Pins

06 November 2018

Joint prosthesis, shoulder

MHRA reference: 2018/011/013/701/003

Fast Track Diagnostics: FTlyo2+.1; FTlyo2P.3; FTlyo48.1; FTlyo56.1

November 2018

IVDs, bacteriology

MHRA reference: 2018/011/009/701/011

Olympus: QIL 151-006

16 November 2018

Endoscopes, flexible

Model: Various

MHRA reference: 2018/011/015/291/002

Oscor: TB Series - Bipolar Pacing Leads

1035166-09/07/2018-01-R MDSS ref: MDD18.249

Implants, active, pacing leads, temporary

Model: Unshrouded Version Only

MHRA reference: 2018/011/014/701/014

Pennine: Prestrol Suction Catheter – FG/CH 7 (2.3mm), 48cm

14 November 2018

Suction system catheter general-purpose

MHRA reference: 2018/011/013/291/002

Randox: Liquid Protein Calibrators

12 November 2018

IVDs, clinical chemistry

Model: IT2692

MHRA reference: 2018/011/006/601/001

Randox Laboratories: Evidence Investigator

12 November 2018

IVDs, clinical chemistry

MHRA reference: 2018/011/012/601/003

RaySearch Laboratories: RayStation

12 November 2018

Radiotherapy planning and verification systems

Model: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A

MHRA reference: 2018/011/014/701/015

Sartorius: Minisart® NML

14 November 2018

Infusion & transfusion, administration sets

MHRA reference: 2018/011/015/487/015

Stryker: LFIT Anatomic CoCr V40 Femoral Heads

18 October 2018

Joint prosthesis, hip

MHRA reference: 2018/011/013/291/008

Talley Group: Venturi Compact

08 November 2018

Active wound management

MHRA reference: 2018/011/016/291/002

Thermo Fisher Scientific: Oxoid Thermo Scientific CLED Agar + Andrades Indicator

08 November 2018

IVDs, bacteriology

MHRA reference: 2018/011/009/601/009

Volcano Corporation (Philips): Visions PV .035 IVUS Catheter

09 November 2018

Ultrasound, imaging

MHRA reference: 2018/011/013/291/009

Zimmer: NexGen Distal Femoral Augment Block

09 November 2018

Joint prosthesis, knee

MHRA reference: 2018/011/009/487/013

Published 19 November 2018