Field Safety Notice: 03 to 07 June 2019

List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 June 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

Aesculap AG FSCA 234: DISP, FLEECE DRAPE F/GA419/GD417/GD421

06 June 2019

Surgical drapes, gowns, masks

MHRA reference: 2019/006/006/701/018

Aesculap AG: UNI-Graft® K DV (12 mm/15 cm)

06 June 2019

Implants, non active, surgical vascular grafts & patches

MHRA reference: 2019/006/006/701/019

AngioDynamics: Solero MTA System and Solero MTA Applicator

17 April 2019

Therapy tissue ablation

Model: H78712740000

MHRA reference: 2019/004/025/291/005

Beckman Coulter: Power Express, AU5800 Conn XL PW21

21 May 2019 IVDs, clinical chemistry

MHRA reference: 2019/005/024/601/006

DIAsource: VIP RIA (Vasoactive intestinal polypeptide)

04 May 2019

IVDs, clinical chemistry

MHRA reference: 2019/006/005/291/008

Diffuplast (Baxter): ExactaMix

05 June 2019

Feeding systems and tubes

Model: 1420.0D/5

MHRA reference: 2019/006/005/701/016

ES-Medical: C-10 Probetester

27 May 2019 Cssd wash/clean/drying equipment

MHRA reference: 2019/006/003/291/008

Edwards LifeSciences: IntraClude Intra-Aortic Occlusion Device

30 May 2019

Vascular cannula and catheters

Model: ICF100

MHRA reference: 2019/006/006/291/001

Fast Track Diagnostics: FTD Lyophilized products

04 June 2019

IVDs, viral microbiology

MHRA reference: 2019/006/005/291/005

GE: Senographe Pristina and Pristina Serena FMI 12283 Mammography MHRA reference: 2019/005/031/487/001

GE: Centricity Universal Viewer with CPACS Foundations

FMI 85452

Picture archiving and communication system (PACS)

MHRA reference: 2019/006/003/291/001

GE Healthcare: Vscan Extend


Ultrasound, imaging

MHRA reference: 2019/005/029/701/050

Gambro (Baxter): Prismaflex System, Prismaflex 4.11, Prismaflex 5.0

17 May 2019

Dialysis, haemodialysis

Model: • 114870

MHRA reference: 2019/005/017/487/003

Hologic: Aptima Combo 2 Assay

June 2019

IVDs, bacteriology Aptima Combo 2 Assay

MHRA reference: 2019/006/004/601/00

LifeTech Scientific: Cera Plug Delivery Cable

15 May 2019

Implants, non active, embolisation products

Model: 3F delivery cable, being pre-assembled together with Plug

MHRA reference: 2019/005/022/487/005

Medtronic: GuardianTM Connect Application

May 2019

Continuous glucose monitoring systems (CGMS)

Model: CSS7200

MHRA reference: 2019/005/030/228/003

Nobel Biocare: Healing Abutment CC RP Ø3.6x5mm


Implants, dental

MHRA reference: 2019/005/024/701/010

Pega Medical: Simple Locking Intramedullary (SLIM) System


Orthopaedic surgical instruments - Insertion/extraction tools

Model: SLM-HND100

MHRA reference: 2019/005/030/601/006

Philips: HeartStart MRx Defibrillator/Monitor

May 2019

Defibrillators, non-Implantable Model: 861288 (M3535A), 861289 (M3536A), 861464 (M3536M), 861465 (M3536MC), 861481 (M3536M2), 861482 (M3536M3), 861483 (M3536M4), 861484 (M3536M5), 861491 (M3536M6), 860396 (M3536M7), 860397 (M3536M8), 860398 (M3536M9), 861287 (M3539A) AC Power Module

MHRA reference: 2019/006/003/291/003

QIAGEN: QIAsymphony Filter Tips, 1500µl (1024)

31 May 2019

IVDs, viral microbiology

MHRA reference: 2019/006/003/701/013

Roche: Accu-Chek® Insight


Infusion systems

MHRA reference: 2019/006/006/701/023

Sacci Ryggsäckar AB: Sacci Infusion Thermo Bag

15 May 2019

Infusion & transfusion, administration sets

MHRA reference: 2019/005/021/487/004

Siemens Healthcare: I VDs, Extra Laboratory Testing

May 2019

IVDs, extra laboratory testing

MHRA reference: 2019/006/005/601/003

Telelfex Medical: Pleur Evac

05 June 2019

Chest drains and accessories

MHRA reference: 2019/006/005/701/009

Telelfex Medical: Auto Endo5 ML

24 May 2019

Clip appliers

MHRA reference: 2019/005/024/701/034

Published 10 June 2019