Field safety notices - 9 to 13 March 2015

List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 2015.

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

Boston Scientific: Biliary Drainage Catheter and Biliary Drainage

9 March 2015

Wound drains

Model: Expel™ Drainage Catheter with Twist-Loc™ Hub

MHRA reference: 2015/003/004/131/004

Candela: GentleLase Pro

19 November 2013

Therapy, lasers

Model: 9914-00-9015

MHRA reference: 2015/003/009/121/011

Chien Ti Enterprise Co.: Leo / Comet / Orion

2 March 2015

Scooters, powered

Model: Leo / Comet / Orion

MHRA reference: 2015/003/003/081/024

Fresenius Medical Care: FX CorDiax 40, 50, … 120 and FX CorDiax HDF600

9 March 2015

Dialysis, haemodialysis

Model: F00001588, F00001589, F00001590, F00001591, F00001592, F00002384, F00005649, F00005650, F00005651, F00005652, F00001593, F00001594, F00001595

MHRA reference: 2015/003/010/081/017

Galt Medical Corporation: 4.5FG SELDINGER TECHNIQUE 7CM SHEATH

10 March 2015

Vascular cannula and catheters

Model: G1146-457

MHRA reference: 2015/003/011/601/005

Medex: FlowSENS

2 March 2015

Media injectors

Model: FlowSENS

MHRA reference: 2015/002/009/081/022

Medicina: IVL60 (INS) 60ml Luer Lock IV Syringe for Insulin

22 October 2014

Device description: insulin injection devices

MHRA reference: 2014/010/016/601/005

Medicina: Medicina Blue Gastrostomy Clip

2 March 2015

Feeding systems and tubes

Model: GC01

MHRA reference: 2015/002/017/601/014

Medicina: Medicina Purple Syringe Pump

2 March 2015

Feeding systems and tubes

Model: P700

MHRA reference: 2015/002/017/601/015

Medicina: Medicina Oral Tip Bulk (non-sterile)

2 March 2015

Feeding systems and tubes

Model: OTCB500

MHRA reference: 2015/002/017/601/016

Medicina: Medicina ACE Stopper Dressing

2 March 2015

Wound management

Model: SD02

MHRA reference: 2015/002/017/601/019

Ortho Clinical Diagnostics

February 2015

IVDs, blood transfusion

Model: ORTHO VISION analyser for ORTHO BioVue Cassettes

MHRA reference: 2015/002/013/601/001

Ossur: LP Rotate

2 March 2015

Prostheses

Model: LP Rotate; LRP062,LRF062,LRPU62,LRFU62

MHRA reference: 2015/003/005/081/028

Philips Healthcare: IntelliVue Clinical Information Portfolio (ICIP); 865047, 865209, 866072, 866148

29 October 2014

Monitors, patient

Model: IntelliVue Clinical Information Portfolio (ICIP); 865047, 865209, 866072, 866148 /

MHRA reference: 2014/012/001/081/003

Rocket Medical Factories 2- 3-4

25 February 2015

Chest drains and accessories

Model: R54565

MHRA reference: 2015/003/006/601/006

Siemens Medical Solutions Diagnostics: IMMULITE 2000, IMMULITE 2000XPi

March 2015

IVDs, clinical chemistry

Model: IMMULITE® 2000, IMMULITE® 2000 XPi

MHRA reference: 2015/003/009/601/001

Siemens Medical Solutions Diagnostics: ADVIA Centaur XPT

March 2015

IVDs, clinical chemistry

Model: ADVIA Centaur XPT

MHRA reference: 2015/003/009/601/012

Stryker Instruments: System 6 Aseptic Housing Battery

10 February 2015

Surgical power tools

Model: System 6 Aseptic Housing Battery

MHRA reference: 2015/001/020/081/002

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