Field Safety Notice - 05 November to 09 November

List of field safety notices (FSNs) from medical device manufacturers from 05 November to 09 November

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

Abiomed: Impella 2.5 Herzpumpe, Impella CP Herzpumpe

20 September 2018

Cardiac assist pumps

Model: 0046-3061, 0048-3075, 0048-0010, 0048-0008

MHRA reference: 2018/011/006/291/004

Ad-Tech Medical Instrument: Drill Sleeve Guide

02 May 2018

Surgical power tools

MHRA reference: 2018/011/001/601/004

Allurion Technologies: Elipse Filler Kit

0066

Implants, non active, gastrointestinal

Model: 11A

MHRA reference: 2018/011/007/291/012

Boston Scientific: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system's SQ-RX™ Model 1010 Pulse Generator (PG)

November 2018

Implants, active, defibrillators

Model: SQ-RX™ Model 1010

MHRA reference: 2018/011/006/487/005

CellPath: CLARITEX WHITECOAT SLIDE

15 October 2018

IVDs, cytopathology & histopathology

MHRA reference: 2018/011/008/701/031

Changzhou: Disposable skin stapler

01 November 2018

Staples and staple guns

MHRA reference: 2018/011/005/291/008

Eurotrol: Eurotrol Hemoglobin Controls

22 October 2018

IVDs, haematology

MHRA reference: 2018/010/030/701/009

GE: Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda iRes Warmer

FMI 332064

Infant incubators

MHRA reference: 2018/011/006/291/010

GE: Aisys, Aisys CS2

FMI 34094

Anaesthetic machines & monitors

MHRA reference: 2018/011/006/291/014

Mediplus

09 November 2018

Injection devices

MHRA reference: 2018/011/008/601/003

Medtronic: Medtronic StrataMR Adjustment Tool Kit

November 2018

Implants, non active, hydrocephalus shunts

Model: 45905

MHRA reference: 2018/011/008/291/008

Novacor: R.Test Evolution 4

12 October 2018

ECG

MHRA reference: 2018/011/006/291/007

Ortho-Clinical: VITROS: Folate, FreePSA, FSH, Prolactin & TSH

November 2018

IVDs, clinical chemistry 1513266, 6842845, 1931922, 1849793, 1912997

MHRA reference: 2018/007/023/601/001

Southmedic: Uresta Bladder Support

05 November 2018

Implants, non-active, implantable incontinence and prolapse devices UR202, UR202-EU, UR203, UR204, UR205, UR206, UR206-EU

MHRA reference: 2018/011/007/291/002

Thermo Fisher: Oxoid Brilliance VRE Agar

08 November 2018

IVDs, bacteriology

MHRA reference: 2018/011/008/601/012

Zimmer: Various Trauma Guide Wires

06 November 2018

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2018/011/007/291/017

Updates to this page

Published 12 November 2018