Field Safety Notices - 13 February - 17 February 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 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

Abbott Laboratories: CELL-DYN Ruby

13 February 2017

IVDs, haematology

MHRA reference: 2017/002/015/701/002

Abbott Vascular: StarClose SE Vascular Closure System

10 February 2017

Vascular closure device

Model: StarClose SE Vascular Closure System; 14679 (US), 14679-01 (China), 14679-02 (Europe, Middle East, Africa, Latin America, Canada and Asia Pacific)

MHRA reference: 2017/002/008/291/008

Animas Corporation: Animas Insulin Pumps

19 September 2016

Infusion systems

Model: Animas Vibe Insulin Pumps

MHRA reference: 2017/001/030/601/017

B. Braun: Dialog+

19 November 2015

Dialysis, haemodialysis

Model: Dialog+

MHRA reference: 2015/011/020/291/001

Bio-Rad: ID-DiaCell's

10 February 2017

IVD, genetic testing

Model: ID-DiaCell's

MHRA reference: 2017/002/013/291/011

BioCardia: Fluid/device delivery cardiac catheter

15 February 2017

Implants, non-active, cardiovascular heart valves

Model: 00953L

MHRA reference: 2017/002/015/601/004

CareFusion: Alaris Plus Syringe Pump

1 February 2017

Infusion systems

Model: 8005TIG01

MHRA reference: 2017/002/016/291/014

Chalice Medical: ParaTherm

10 February 2017

Blood/Fluid warming systems

Model: Paratherm

MHRA reference: 2017/002/014/601/009

Coris BioConcept: RESIST-3 O.K.N. K-set

13 February 2017

IVDs, bacteriology

Model: RESIST-3 O.K.N. K-set Cassette

MHRA reference: 2017/002/014/299/017

Depuy Synthes: Distractor; Removal Tool; Retractor; Inserter

15 February

Orthopaedic surgical instruments - Insertion/extraction tools Model: Distractor; Removal Tool; Retractor; Inserter 396.396; 03.812.005; 03.632.087; 03.820.129 MHRA reference: 2017/002/014/299/028

Ella-CS: SX-ELLA Stent Danis Procedure Pack (Basic)

14 February 2017

Implants, non-active, non-vascular stents

MHRA reference: 2017/002/015/291/004

Euro Diagnostica: DIASTAT ANA ELISA

15 February 2017

IVDs, Immunology

MHRA reference: 2017/002/016/299/005

Greatbatch Medical: MOBICATH™ Bi-Directional Guiding Sheath

2183787-02/07/2017-001-R

Vascular cannula and catheters

MHRA reference: 2017/002/015/701/012

Gyrus ACMI: Gyrus ACMI Diego Elite Tubeset

January 2017

Surgical equipment, miscellaneous Model: Gyrus ACMI Diego Elite Tubeset; TS100S, TS101DC

MHRA reference: 2017/002/010/601/007

Hoya Corporation: PENTAX Ultrasound-Video Bronchoscope

FSCA-PMJ-16-03-1

Endoscopes, flexible

Model: EB-1970UK PENTAX Ultrasound-Video Bronchoscope

MHRA reference: 2017/002/001/291/014

LivaNova: FlexTherm Device

6 February 2017

Blood/fluid warming systems

Model: 16-70-00

MHRA reference: 2017/002/016/299/006

Medtronic MiniMed: MiniMed 640G Insulin Pump

February 2017

Ambulatory insulin infusion pump

Model: MMT-1711, MMT-1712

MHRA reference: 2017/002/001/291/017

MicroPort Orthopedics: BIOLOX FORTE 36mm Alumina ceramic head

8 February 2017

Joint prosthesis, hip

Model: 26000010, 26000011, 26000012

MHRA reference: 2017/002/010/291/013

Pennine Healthcare: Covidien Devon Light Glove

3 February 2017

Lamps & lights

MHRA reference: 2017/002/013/701/019

Roche: cobas p 612 pre-analytical system

15 December 2016

IVDs, clinical chemistry

Model: 07563116001

MHRA reference: 2016/012/020/701/016

Spacelabs Healthcare: Arkon Anesthesia Delivery System

15 February 2017

Anaesthetic machines & monitors

Model: 99999

MHRA reference: 2017/002/015/291/006

Stealth Products: Stealth

8 February 2017

Wheelchairs, accessories

Model: TWB480-17FDM, TWB486-17FDM, TWB480-1FDM, TWB486-1FDM

MHRA reference: 2017/002/009/601/001

WEINMANN Medical Technology: Batteriepack MEDUCORE Easy

February 2017

Defibrillators, non-implantable

Model: Batteriepack MEDUCORE Easy; 40155

MHRA reference: 2017/002/016/291/011

Zimmer: All metal heads including: Modular femoral heads, Protasul S30 femoral heads and Metasul femoral heads

13 February 2017

Joint prosthesis, hip

Model: Modular femoral heads, Protasul S30 femoral heads, Metasul heads that can be used in a metal on polyethylene combination

MHRA reference: 2017/002/013/701/022

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