Field Safety Notice: 09 to 13 September 2019

List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 September 2019.

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

Aesculap: ENDURO SPECIAL KEY TIB.LOCK.RING Fl /10MM

11 February 2019

Orthopaedic surgical instruments - insertion/extraction tools

NP462R

MHRA reference: 2019/009/011/487/012

Beckman Coulter: Multiple Assay

05 September 2019

IVDs, clinical chemistry

A60298 - Enzymatic Creatinine Reagent (CR-E 2 x 200)

445850 - Triglycerides GPO Blanked Reagent (TG-B 2 x 300)

442785 - Uric Acid Reagent (URIC 2 x 300)

439715 & 476856 Direct Bilirubin Reagent (DBIL 2 x 200)

442745 & 476861 Total Bilirubin Reagent (TBIL 2 x 300)

MHRA reference: 2019/009/006/601/004

GE: Aespire 7100, Aestiva 7900/MRI/7100/100

GEHC Ref: 34101

Anaesthetic machines & monitors

MHRA reference: 2019/009/010/228/018

Gentherm Medical: Blanketrol III

01 August 2019

Heating, patient, electrical pads & blankets 233

MHRA reference: 2019/009/010/228/0182

HemoCue: HemoCue® Glucose 201 DM RT Analyzer

10 September 2019

IVDs, haematology

MHRA reference: 2019/009/010/701/014

LabStyle Innovations: Dario-Blood Glucose Tracker (Android Application)

FA-2019-01; MDSS ref.: IVD19.039

IVDs, self / home testing

1022-02

MHRA reference: 2019/009/011/487/016

Medtronic: Euphora Rapid Exchange Balloon Dilatation Catheter / Solarice Rapid Exchange Balloon Dilatation Catheter

September 2019

Vascular cannula and catheters

MHRA reference: 2019/009/009/291/004

Molnlycke Health Care: Barrier® Sets

29 August 2019

Surgical drapes, gowns, masks

MHRA reference: 2019/008/029/701/018

NxStage Medical: NxStage System One

27 August 2019

Dialysis, haemodialysis

NX1000-1, NX1000-3, NX1000-3-A

MHRA reference: 2019/009/010/701/007

Pajunk: SPROTTE Lumbar

30 August 2019

Injection devices

321151-30C, 331151-31B

MHRA reference: 2019/009/010/601/001

Philips: S7-3t & S8-3t Transesophageal (TEE) Transducers

28 August 2019

Ultrasound, imaging

MHRA reference: 2019/009/009/291/001

Shimadzu: FDR Go

28 June 2019

X ray, mobiles

DR-ID 800

MHRA reference: 2019/009/005/701/020

Teleflex: DispoGrip

06 September 2019

Airway devices

MHRA reference: 2019/009/009/291/002

Terumo: Optia software version 11

27 August 2019

Apheresis

Optia software version 11

MHRA reference: 2018/010/001/401/004

Updates to this page

Published 20 September 2019