Field safety notices - 12 to 16 October 2015

List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 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

Alere Connected Health: ImmunoComb® II HIV 1&2 Bispot

25 August 2015

IVDs, viral microbiology

MHRA reference: 2015/009/003/292/007

B Braun Avitum AG: single - needle-adapter ETO

14 October 2015

Dialysis, blood lines

Model: 7210868

MHRA reference: 2015/010/014/601/014

Bridge to Life: Belzer UW(R) Cold Storage Solution

7 October 2015

Storage and collection devices

MHRA reference: 2015/010/009/601/013

CareFusion: Alaris® Pump Model

October 2015

Infusion systems

Model: 8110

MHRA reference: 2015/010/006/299/002

Coloplast: Testicular Implant (35277) and Vaginal Stent (35646)

9 October 2015

Implants, Reconstructive, Body Contouring

Model: R3001, PR3002, PR3003, PR3004, PR3005, VS3020, VS3022, VS3024 and VS3026

MHRA reference: 2015/010/009/299/003

Cook Medical: Beacon Tip Angiographic Catheters

8 October 2015

Vascular cannula and catheters

MHRA reference: 2015/007/013/291/011

Dräger Medical:

June 2015

Anaesthetic machines & monitors

Model: Fabius MRI

MHRA reference: 2015/006/016/291/001

eVent Medical: Inspiration Ventilatory System

12 October 2015

Lung ventilators

MHRA reference: 2015/010/005/292/004

Galil Medical: IceRod 1.5 PLUS Cryoablation Needle

6 October 2015

Surgical, cryogenic

Model: FPRPR 3508

MHRA reference: 2015/010/012/601/015

Hospira UK: Plum 360 Infusion Pump

14 October 2015

Infusion systems

Model: Attached

MHRA reference: 2015/010/009/051/003

Johnson & Johnson: PowerStar Bipolar Cable

30 September 2015

Infusion systems

MHRA reference: 2015/010/008/292/015

MAQUET Cardiopulmonary AG: Heater Cooler Unit 30

13 October 2015

Infusion & Transfusion, heart lung circuits

Model: Heater-Cooler Unit 30 with Serial Number <93101480, HCU 30 Base Unit 100-120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 - 240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653

MHRA reference: 2015/010/015/292/003

Philips Medical: Allura Xper

FCO72200324

X Ray, fluoroscopy systems

Model: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 72205

MHRA reference: 2015/010/013/292/019

Riverside Medical Packaging Company

1 October 2015

Infusion and transfusion, administration sets

Model: Aseptic Medical Devices (AMD) Sterile Compounding Procedure Packs, S10A03A, S25A03A, SING001, S05A05A, S10A05A, S25A05A, STTH001, DERR001, STTH002

MHRA reference: 2015/010/001/601/003

Siemens Healthcare Diagnostics: ADVIA Chemistry XPT System

October 2015

IVDs, clinical chemistry

Model: SMN 10723034

MHRA reference: 2015/010/013/601/007

Stryker Orthopaedics-Mahwah: MIS Distal Captures

October 2015

Surgical Instruments, Implant

Model: MIS Distal Captures 6541-5-723

MHRA reference: 2015/010/015/292/001

Thermo Fisher: Oxoid™ M.I.C.Evaluator™ (M.I.C.E.™)

October 2015

Oxoid™ M.I.C.Evaluator™ (M.I.C.E.™) (MA0101D/F Penicillin 256μg/ml )

IVDs, bacteriology

MHRA reference: 2015/010/014/601/016

Tornier: Radial Head Prosthesis

13 October 2015

Joint Prosthesis, elbow

Model: Radial Head Prosthesis

MHRA reference: 2015/010/014/291/001

Ventana Medical: Virtuoso software version 5.4 and 5.5 Image Measurement issue

7 October 2015

IVDs, cytopathology & histopathology

Model: catalogue number: 07299303001(v5.4), 07073984001(v5.5)

MHRA reference: 2015/010/013/292/004

Wescott Medical: Wescott

9 October 2015

Infusion & transfusion, administration sets

Model: WEARY-2

MHRA reference: 2015/010/009/601/017

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.