Field safety notices - 4 January to 8 January 2016

List of field safety notices (FSNs) from medical device manufacturers from 4 January to 8 January 2016.

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

Applied Medical Technology: TLC self-retaining retractor frame system

5 January 2016

Surgical instruments, minimal access

MHRA reference: 2016/001/005/292/018

Bard: Arctic Sun temperature management system

FA2015-30

Heating, patient, electrical pads & blankets

MHRA reference: 2015/011/012/601/016

B Braun: Certofix Quattro v 815

24 December 2015

Vascular cannula and catheters Model: Certofix Quattro

MHRA reference: 2015/012/021/291/022

Boston Scientific Corporation: Chariot guiding sheath

17 December 2015

Vascular cannula and catheters

MHRA reference: 2015/011/023/292/008

Caesarea Medical Electronics: T60 ambulatory syringe pump, TPCA PCA syringe pump

16 December 2015

Infusion systems

Model: 100-100PSLM, 100-106PSLMTPCA, PMP00007

MHRA reference: 2015/010/026/291/007

Caesarea Medical Electronics: T34 ambulatory syringe pump

12 October 2015

Infusion systems

Model: 100-100SM

MHRA reference: 2015/010/026/291/006

Cyberonics: VNS Therapy Aspire SR generator

15-005

Implants, active, stimulators, neuro

Model: 106

MHRA reference: 2015/011/024/292/021

Cytosorbent: Haemoperfusion system adsorption column

22 December 2015

Dialysis, haemofilters

Model: CytoSorb© 300mL Device

MHRA reference: 2015/012/029/292/003

Depuy Synthes: Extraction screw for PFNA blade

30 December 2015

Surgical instruments, implant

Model: 356.825

MHRA reference: 2016/001/004/291/002

Immucor Inc: LIFECODES HLA-DQA1/B1 typing kit

30 December 2015

IVDs, immunology

Model: 628930

MHRA reference: 2016/001/004/292/005

Medtronic: Specify 5-6-5 surgical lead and Specify 2x8 surgical lead

6 January 2016

Implants, active, leads, neuro

Model: 39565 and 39286

MHRA reference: 2016/001/005/292/010

Nutricia: Flocare infusion sets with ENFit transition adaptors

7 January 2016

Feeding systems and tubes

MHRA reference: 2015/012/010/302/001

Rayner Intraocular Lenses: C-flex Aspheric, Superflex Aspheric, Sulcoflex Aspheric, Sulcoflex Toric and T-flex Aspheric

1 January 2016

Implants, non-active, intraocular

Model: 970C, 920H, 653L, 653T, 573T and 623T

MHRA reference : 2016/001/001/601/001

Roche Diagnostics: cobas b 123

23 December 2015

IVDs, extra laboratory testing

Model: cobas b 123 fluid pack 200 (Cat. No. 05403308001) cobas b 123 fluid pack 400 (Cat. No. 05403154001) cobas b 123 fluid pack 700 (Cat. No. 05403286001) cobas b 123 fluid pack COOX 200 (Cat. No. 05169992001) cobas b 123 fluid pack COOX 400 (Cat. No. 05170036001) cobas b 123 fluid pack COOX 700 (Cat. No. 05170052001)

MHRA reference: 2016/001/007/292/002

Siemens Healthcare Diagnostics: ADVIA Centaur Systems PSA

4 January 2016

IVDs, clinical chemistry

MHRA reference: 2016/001/004/601/003

St. Jude Medical: All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.

December 2015

Implants, active, pacemakers

MHRA reference: 2015/008/019/291/003

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