Field Safety Notice - 23 to 27 April 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 April 2018.

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

Becton Dickinson: Alaris SMARTSITE ADD-ON BAG ACCESS DEVICE

April 2018

Infusion & transfusion, administration sets

MHRA reference: 2018/004/019/291/003

Becton Dickinson: Model 8100

April 2018

Infusion Systems

MHRA reference: 2018/004/020/478/001

Boston Scientific: INGEVITY™ MRI Extendable/Retractable Fixation leads

April 2018

Implants, active, leads and electrodes

Model: 7740, 7741, 7742

MHRA reference: 2018/004/026/291/011

Cutting Edge: SIP – SIPY – SISA – SISA* – SISAY

28 March 2018

Implants, non active, intraocular

MHRA reference: 2018/003/029/401/006

Edwards Life Sciences: IntraClude™ intra-aortic occlusion device ICF100

April 2018

Vascular cannula and catheters

MHRA reference: 2018/004/009/291/036

Illumina: MiSeqDx Instrument

18 April 2018

IVD, genetic testing

15036706

MHRA reference: 2018/004/020/601/007

Microclean: MicronDevices Sterile Packs

24 April 2018

Injection devices

MHRA reference: 2018/003/022/291/002

Ortho Solutions: RECIPROCATING BLADE 68.0MM X 1.2MM TOOTHED BOTH SIDES

13 March 2018

Surgical power tools

Model: OSA11-912

MHRA reference: 2018/004/022/601/001

Roche Diagnostics: For list of devices see "Accessories"

April 2018

IVDs, clinical chemistry

MHRA reference: 2018/004/018/701/015

Roche Diagnostics: Urisys 1100

April 2018

IVDs, clinical chemistry

Urisys 1100 03617548001

MHRA reference: 2018/004/020/291/005

Siemens: Dimension Gentamicin, Dimension Vista Gentamicin

April 2018

IVDs, clinical chemistry

Model: 10444927, 10445120

MHRA reference: 2018/004/025/601/010

Smiths Medical: Thoracic Catheter 16F Angled Soft, Adult Connector

18 April 2018

Chest drains and accessories

800/002/067, 200/812/160; 200/812/200; 200/812/240;

MHRA reference: 2018/004/012/291/011

Stryker: T2 Ankle Arthrodesis / Femur / Tibia / Recon / Greater Trochanter Nails of the T2 Nailing System / see attachm. PFAA_1774317 affected article no_rev1

23 April 2018

Osteosynthesis, nails intramedullary

MHRA reference: 2018/004/024/291/002

Thermo Fisher Scientific: Oxoid

25 April 2018

IVDs, bacteriology

Model: PB0935A

MHRA reference: 2018/004/024/601/002

Torax Medical: LINX Reflux Management System

2018-04-13 R1

Implants, non active, non vascular stents

MHRA reference: 2018/004/024/291/015

Tornier: Aequalis Humerail Nail Drill Bit Sterile

06 April 2018

Joint prosthesis, knee

MHRA reference: 2018/004/011/478/003

Vygon: Vylife, Kit Vylife

12 February 2018

Lung ventilators

Model: Vylife, Kit Vylife 7506.02, 7506.03, 5582.700, 5582.802, 5582.841, 5582.842/844

MHRA reference: 2018/002/019/291/001

Updates to this page

Published 30 April 2018