Field Safety Notice: 19 to 23 August 2019

List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 August 2019.


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

Armstrong Medical

16 August 2019

Breathing system components

Model: 15mmØ Collapsible/Extendible Tubing - present in Armstrong Medical Catheter Mounts, Face Mask Kits and some Breathing Circuits

MHRA reference: 2019/008/016/487/007

B Braun: C0027407, C0026248; G0994318, G0994725; C0024533

09 August 2019


MHRA reference: 2019/008/009/228/002

Boston Scientific: EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD

August 2019

Implants, active, defibrillators

Model A209 - A2019

MHRA reference: 2019/008/021/487/028

Cantel Medical UK: Hook-up for Cantel EWDs

19 August 2019

Cssd wash/clean/drying equipment

MHRA reference: 2019/008/016/487/008

CME McKinley: T34 TM Ambulatory Syringe Pump

July 2019

Infusion systems

MHRA reference: 2019/008/019/487/023

DiaMed GmbH: IH-1000

21 August 2019

IVDs, blood transfusion

Model: 001000

MHRA reference: 2019/008/022/701/009

Flowonix Medical: Prometra Programmers (REF 91828)

12 August 2019

Implants, active, infusion pumps

Model: Prometra Programmers (REF 91828) (Software version 1.03, 1.06, 1.06.1)

MHRA reference: 2019/008/015/487/005

Intersurgical: swivel elbows

25 July 2019

Breathing System Components

MHRA reference: 2019/007/019/291/001

Philips: Efficia DFM 100

August 2019

Defibrillators, non-implantable

Model: 866199

MHRA reference: 2019/008/015/487/030

Roche - EFSN cobas: AssayTip/AssayCup tray

06 August 2019

IVDs, clinical chemistry

MHRA reference: 2019/008/009/487/008

Roche: STFR.

August 2019

IVDs, clinical chemistry

MHRA reference: 2019/008/016/701/008

Siemens: Atellica IM anti-CCP IgG (aCCP) assay Atellica IM Pregnancy-Associated Plasma Protein-A assay

August 2019

IVDs, immunology

MHRA reference: 2019/008/019/601/008

Siemens - ASI 19-04: Atellica CH 930 Analyzer

August 2019

IVDs, clinical chemistry

MHRA reference: 2019/008/020/601/006

Siemens: Atellica IM 1300 and IM 1600 Analyzers

August 2019

IVDs, clinical chemistry

MHRA reference: 2019/008/020/601/010

Spierings Orthopaedics: REX Cement Stop TM

22 August 2019

Joint prosthesis, hip

REX Cement Stop ø9, REX Cement Stop ø10, REX Cement Stop ø11.5, REX Cement Stop ø13.5, REX Cement Stop ø16

MHRA reference: 2019/008/022/701/008

St. Jude Medical

22 August 2019

CentriMag motor, OUS


MHRA reference: 2019/008/022/291/004

Stryker: MESA 2 Deformity Polyaxial Screw; Size Ø6.5x45 mm

05 August 2019

Osteosynthesis, bone screws

MHRA reference: 2019/008/012/701/010

Stryker: Triathlon

14 August 2019

Joint prosthesis, knee

MHRA reference: 2019/008/012/701/006

Surgical Specialties - Altomed: UltraPlug

13 August 2019

Implants, non-active, intraocular

Model: A10212 (Manufacturer code PPLUG6)

MHRA reference: 2019/008/015/601/003

The Binding Site: Optilite C-Reactive Protein Reagent

20 August 2019

IVDs, clinical chemistry


MHRA reference: 2019/008/019/601/013

The Binding Site: VaccZyme™ Human Anti-Haemophilus Influenzae type b

21 August 2019

IVDs, immunology


MHRA reference: 2019/008/008/601/005

Vascular Solutions - Teleflex: TrapLiner Catheter

21 August 2019

Vascular cannula and catheters

MHRA reference: 2019/008/021/701/024

Zimmer: Sidus® Stem-Free Shoulder Humeral Head 50-18

19 August 2019

Joint prosthesis, shoulder

MHRA reference: 2019/008/019/291/013

Published 28 August 2019