Field Safety Notices - 13 - 17 June 2016

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 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

Aspen Medical: Sorbsan

ASPEN R02-2016

Wound management

Model: 1400, 1410, 1415, 1412, 1411, 1420, 1421, 1422, 1423, 1420SA, AG1400 1421SA, 1422SA, 1423SA, 1400N, 1403S, 1410N, 1410S, 1413S, 1415N, 1415S, 1418S

MHRA reference: 2016/005/006/701/007

Beckman Coulter: Access Free T3

15 June 2016

IVDs, clinical chemistry

Model: Access Free T3

MHRA reference: 2016/006/015/601/011

Benmor Medical

NCR0039

Beds and accessories

Model: Aurum

MHRA reference: 2015/005/026/401/023

Cook: Biodesign® Anal Fistula Plug

13 June 2016

Implants, non-active, abdominal & hernia mesh

Model: C-AFPS-0.6X9.5

MHRA reference: 2016/006/015/291/001

Depuy Synthes: Craniofacial bone distractor

08 June 2016

Orthopaedic surgical instruments - measuring tools

Model: [1] 487.962; [2] 487.963; [3] 487.964; [4] 487.965; [5] 487.974; [6] 487.975

MHRA reference: 2016/006/013/291/002

Draeger

June 2016

Infant, warmers

Model: Babytherm 8004 & Babytherm 8010

MHRA reference: 2016/006/014/291/002

Edwards: EV1000 Clinical platform system

03 May 2016

Monitors, patient

Model: EV1000A

MHRA reference: 2016/006/010/701/010

Fisher & Paykel: AIRVO2 Humidifier / myAIRVO2 Humidifie

FA-2016-001 Humidifiers Model: PT101 / PT100

MHRA reference: 2016/006/010/299/009

GE Medical: Discovery 3.0T MR750

FMI 60888-SW Magnetic resonance, equipment & accessories Model: Discovery 3.0T MR750 used with the 3.0T 6 Channel Flex Coil

MHRA reference: 2016/006/007/299/009

Miris: Miris Human Milk Analyzer (HMA) 10-02-001

20 May 2016

IVDs, clinical chemistry

MHRA reference: 2016/006/014/131/002

Lohmann & Rauscher: Metalline wound, drainage, tracheo dressings

09 June 2016

Basic dressings, absorbents, swabs, procedure packs

MHRA reference: 2016/006/010/299/006

Medcomp

14 June 2016

Vascular cannula and catheters Model: Pro-PICC CT; Pro-Line CT

MHRA reference: 2016/006/013/291/023

PerkinElmer: Sterile Filter Tips, 25ul, Nonconductive

16 May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/025/701/006

QIAGEN: QIAsymphony DSP DNA & Virus/Pathogen Kits

13 June 2016

IVD, genetic testing

MHRA reference: 2016/006/015/701/001

Rex Bionics: REX Rehab

17 June 2016

Orthoses

MHRA reference: 2016/006/009/299/002

Roche: Multiplate® Analyzer

10 June 2016

Coagulation

Model: 06675069001

MHRA reference: 2016/006/015/701/002

Siemens: Dimension

# ® & Dimension Vista # ® Creatinine

08 June 2016

IVDs, clinical chemistry

MHRA reference: 2016/006/010/601/007

Smith & Nephew:LEGION HK BOLT AND SLEEVE

14 June 2016

Joint prosthesis, knee

MHRA reference: 2016/006/015/291/020

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