Field Safety Notices - 27 June - 1 July 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 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

Allurion Technologies: Elipse Device

29 June 2016

Implants, non-active, gastrointestinal

Model: REF 10 and REF 10A

MHRA reference: 2016/006/030/291/019

B. Braun: Dialog, Dialog Advanced, Dialog+

23 June 2016

Dialysis, haemodialysis

Model: please see annex 1

MHRA reference: 2016/003/021/292/001

Biofrontera Pharma: BF-RhodoLED

29 June 2016

Therapy, adult phototherapy

MHRA reference: 2016/006/015/071/004

Biomet: Hard Tissue Replacement Polymer Implants

13 June 2016

Implant materials, bone substitutes

MHRA reference: 2016/006/023/291/014

Biosynex: Biosynex Exacto Pro test HIV - HIV16010004

8 June 2016

IVDs, viral microbiology

MHRA reference: 2016/006/010/299/021

ConMed Corporation: Core Suction Irrigation Handpieces

05 July 2016

Surgical equipment, miscellaneous

MHRA reference: 2016/006/024/701/005

Delcath Systems:CHEMOSAT Hepatic Delivery System

2 May 2016

Vascular cannula and catheters

Model: 400021, 400002

MHRA reference: 2016/006/015/601/013

Ivoclar Vivaden: OptraPol Small Flame / OptraPol Cup Refill

June 2016

Dental appliances / instruments

MHRA reference: 2016/006/022/071/004

Lifetech Scientific: CeraFlex™ Atrial Septal Defect (ASD) Occlude

14 March 2016

Implants, non-active, cardiac appendage and septal defect occluders / plugs

Model: L T-ASDf-OS/08/ .. /30/32

MHRA reference: 2016/003/004/292/003

Medtronic Xomed Inc.:NIM® Standard Reinforced EMG Endotracheal Tube, NIM Contact® Reinforced EMG Endotracheal Tube

29 June 2016

Airway devices

MHRA reference: 2016/006/030/291/002

Medtronic: 1x4 DBS Restore Adaptor and 2x4 DBS Restore Adaptor

23 June 2016

Implants, active, stimulators, neuro

Model: 64001, 64002

MHRA reference: 2016/006/023/291/002

MicroVention: PHIL (Precipitating Embolic Injectable liquid) Non-Adhesive Liquid Embolic System

FCA#2016-01

Implants, non-active, embolisation products

Model: LEN10250, LEN10300, LEN10350

MHRA reference: 2016/006/027/291/012

Miele & Cie: Olympus ETD 4

June 2016

Cssd wash/clean/drying equipment

MHRA reference: 2016/006/022/701/009

Siemens: ADVIA Chemistry Theophylline Reagent (THEO_2)

June 2016

IVDs, clinical chemistry

MHRA reference: 2016/006/024/601/003

Siemens: Stratus CS Acute Care Diagnostics System

June 2016

IVDs, clinical chemistry

MHRA reference: 2016/006/027/601/003

Smith & Nephew: GENESIS Trocar Pins

28 June 2016

Orthopaedic surgical instruments - measuring tool

MHRA reference: 2016/006/028/701/009

Smith & Nephew: Twinfix Quick-T Knot Pusher Suture Cutters

21 June 2016

Surgical Instruments, manipulating

MHRA reference: 2016/006/016/701/022

Sorin: Heating unit, pad, water, system

21 June 2016

Blood/fluid warming systems

Model: 16-02-50, 16-02-80, 16-02-81, 6-02-82, 16-02-85, 16-02-95, 16‑70‑00 ‑ HeaterCooler & FlexTherm

MHRA reference: 2016/006/023/291/003

Technical Service Consultants: Probact Transport Swab

27 April 2016

IVDs, specimen receptacles

Model: TS/5-17

MHRA reference: 2016/006/027/291/001

Stryker: AutoPlex® System

27 June 2016

Bone cement and tools

Model: 0605-887-000

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

Thermofisher Scientific: Oxoid GC Agar

24 June 2016

IVDs, bacteriology

Model: CM0367

MHRA reference: 2016/006/028/601/004

Zimmer: Twist drill

27 June 2016

Surgical power tools

MHRA reference: 2016/006/027/291/018

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