Field Safety Notices - 6 March - 10 March 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 March 2017

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

Aesculap: MINOP INVENT 30DG TROCAR D8.3MM L150MM

06 March 2017

Surgical instruments, minimal access

Model: FH620R

MHRA reference: 2017/003/006/701/010

B Braun: PROSET INFUSOMAT SPACE LINE PUR/0, 2µm

06 March 2017

Infusion and transfusion, administration sets

Model: 8251284SP

MHRA reference: 2017/003/002/601/007

Becton Dickinson: BD Vacutainer® SST™ II Advance Plus

24 February 2017

IVDs, specimen receptacles

MHRA reference: 2017/002/020/701/019

Gambro: Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row, Prismaflex 7.XX Row, Prismaflex 8.XX Row, Prismaflex

13 March 2017

Dialysis, haemofilters

Model: 107493,113082, 113874, 114489, 114870, 955052, 6023014700

MHRA reference: 2017/003/006/291/043

HOYA: PENTAX Flexible video duodenoscope, PENTAX Flexible fiber duodenoscope

FSCA-PMJ-17-01-1

Endoscopes, flexible

Model: ED-3490TK, ED-3270K, ED-3430, ED-3430TK, ED-3670TK, FD-34V2

MHRA reference: 2017/003/007/291/001

Menicon: Menicon soft 72

13 February 2017

Contact lenses & shells

MHRA reference: 2017/002/014/299/001

Physio-Control: LIFEPAK 1000 AEDs

March 2017

Defibrillators, non-implantable

MHRA reference: 2017/001/019/291/001

Samsung: Mobile Digital X-ray GM60A

FSCA_GM60A_160728006

X ray, mobiles

Model: GM60A

MHRA reference: 2017/001/026/291/001

Siemens: Ammonia Flex reagent cartridge

07 March 2017

IVDs, clinical chemistry Model: Dimension Integrated Chemistry System

MHRA reference: 2017/003/008/601/001

Siemens: Dimension Vista® Systems

March 2017

IVDs, clinical chemistry

MHRA reference: 2017/003/008/601/002

Siemens: ADVIA Centaur BR Assay

March 2017

IVDs, clinical chemistry

MHRA reference: 2017/003/009/601/003

Sysmex: Automated Hematology Analyzer XN-L series XN-550

06 March 2017

IVDs, haematology

Model: XN-550

MHRA reference: 2017/003/009/291/003

Trinity Biotech: Premier Buffer A Reagent, Premier Buffer B Reagent

23 February 2017

IVDs, clinical chemistry

MHRA reference: 2017/003/009/291/018

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