Field Safety Notice: 16 to 20 September 2019

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 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

Abbott: Alinity

16 September 2019

IVDs, clinical chemistry

MHRA reference: 2019/009/018/701/017

Axis-Shield: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT

16 September 2019 IVDs, clinical chemistry Model: FHRWR100/200/1000 and FHBC100 MHRA reference: 2019/009/019/601/001

Baxter: PrisMax, V2, ROW

14 August 2019

Dialysis, haemodialysis

Model: 955558

MHRA reference: 2019/008/015/487/029

Bio-Rad: DC-Screening II

11 September 2019

IVDs, blood transfusion

Model: 50560

MHRA reference: 2019/009/012/228/019

Boston Scientific: iLab™ Polaris Multi-Modality Guidance System

18 September 2019

Ultrasound, imaging

Model: H749009710

MHRA reference: 2019/009/018/487/019

Cordis: Cordis® POWERFLEX® PRO PTA Dilatation Catheter

23 August 2019

Vascular cannula and catheters

MHRA reference: 2019/008/028/291/001

Edwards Lifesciences: EV1000A / EV1000N

FCA-128

Monitors, patient

MHRA reference: 2019/004/024/701/009

Johnson & Johnson: 1-DAY ACUVUE® MOIST®for ASTIGMATISM Contact Lenses

September 2019

Contact lenses & shells

MHRA reference: 2019/009/011/701/011

Maquet (Getinge):

11 September 2019

Infusion & transfusion, heart lung circuits 701067941, 701067942, 701067948, 701067949, 701067951, MHRA reference: 2019/009/012/228/006

Medtronic: Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, Q series Implantable Pulse Generators (IPG) (UPDATE TO FSN 21-25 JANUARY 2019)

September 2019

Implants, active, pacemakers

Model: Distributed between 10 March 2017 and 7 January 2019

MHRA reference: 2019/001/018/291/003

MGB Endoskopische Gerate: GRP handle (with ratchet)

19 February 2019

Surgical instruments, minimal access

Model: 429-77015, 429-77015N, 429-77020, 429-77020N, 429-77030, 429-77030N

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

Ortho-Clinical: VITROS Chemistry Products CL- & K+ Slides

September 2019

IVDs, clinical chemistry

MHRA reference: 2019/009/017/601/001

World of Medicine: Aquilex Fluid Control System

17 August 2019

Infusion systems

Model: AQL-100CBS

MHRA reference: 2019/009/013/487/001

Updates to this page

Published 23 September 2019