Field Safety Notices - 19 - 23 September 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 September 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

AngioDynamics: Celerity Sterile Disposables

7 September 2016

ECG

MHRA reference: 2016/009/019/291/007

B Braun: Spinocath®

15 September 2016

Vascular cannula and catheters

Model: Spinocath® 4517717, 4517725

MHRA reference: 2016/009/016/601/002

Boston Scientific: Lotus™ Valve System

17 May 2016

Implants, non-active, cardiovascular heart valves

Model: H749LTV230, H749LTV250 & H749LTV270

MHRA reference: 2016/004/014/299/016

Buhlmann: Quantum Blue ® Calprotectin Assay, Quantum Blue ® Calprotectin High Range

11 August 2016

IVDs, bacteriology

MHRA reference: 2016/009/019/291/008

Cepheid: Xpert ® HIV-1 Viral Load

16 September 2016

IVDs, viral microbiology

MHRA reference: 2016/009/020/071/002

Codan: Transducer of the DPT-6000er series

12 September 2016

Infusion and transfusion, administration sets

MHRA reference: 2016/008/022/291/003

Flowonix Medical: Prometra® Programmable Pump

20 September 2016

Implants, active, infusion pumps

Model: Prometra® Pump REF 91827; Prometra®Programmer REF 91828; Catheter REF 91823

MHRA reference: 2016/009/005/299/021

ICU Medical: TEGO Connector

06 September 2016

Infusion and transfusion, connectors

MHRA reference: 2016/009/009/701/017

Lemaitre Vascular

21 September 2016

Surgical instruments, non-articulated cutting

Model: 1009-00, 1009-00J

MHRA reference: 2016/009/021/131/008

MI Tech: NES / NESA / EPW range

QF3444

Implants, non-active, non-vascular stents

Model: NES-18-080-070 / NES-18-110-070 / NESA-18-110-070 / EPW-20-100-070 / EPW-20-150-070

MHRA reference: 2016/009/020/601/005

Ohmeda Medical: Ohio Infant Warmer Systems

GEHC Ref# 32047

Infant, warmers

Model: Model 2001 IWS (International), 3000 IWS, 3050 IWS, 3100 IWS, 3150 IWS, 3300 IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS.

MHRA reference: 2016/009/016/29

Philips Healthcare

September 2016

Monitors, patient

Model: MX40

MHRA reference: 2016/009/019/291/034

RaySearch Laboratories

FSN 12171_11861

Radiotherapy planning and verification systems

Model: 2.5, 3.0, 3.5, 4.0, 4.3, 4.5, 4.7, 5.0

MHRA reference: 2016/009/020/701/001

Randox: Evidence Investigator EV3602, EV3602R

02 August 2016

IVDs, clinical chemistry

MHRA reference: 2016/009/019/601/001

Randox: Magnesium on RX Imola MG3880

6 April 2016

IVDs, clinical chemistry

MHRA reference: 2016/009/019/601/002

Roche: Diverse Instruments - Rack Trays

12 September 2016

IVDs, clinical chemistry

MHRA reference: 2016/009/019/701/003

Roche: Cobas c 111

14 September 2016

IVDs, clinical chemistry

Model: Cobas c 111 04528778001/04777433001

MHRA reference: 2016/009/019/701/011

Sofradim Production: Refer to the FSN

14 September 2016

Implants, non-active, abdominal & hernia mesh

Model: Abdominal hernia surgical mesh Parietex™ Plug and Patch System and ProGrip™ Self-Gripping Polyester Mesh

MHRA reference: 2016/009/013/701/002

Trinity Biotech: MicroTrak® Syphilis TPHA PK

20 September 2016

IVDs, bacteriology

Model: D268003

MHRA reference: 2016/009/019/291/029

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