Field Safety Notices - 13 March - 17 March 2017

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

Advanced Medical Solutions (Plymouth): LiquiBand FIX8

3 March 2017

Tissue glues

Model: FX001

MHRA reference: 2017/003/003/601/005

Alere Technologies: Alere Afinion™ Lipid Panel Control

February/March 2017

IVDs, clinical chemistry

MHRA reference: 2017/003/001/701/005

Beckman Coulter: Access 2 System, UniCel DxC 600i Syncron System

14 March 2017

IVDs, clinical chemistry

MHRA reference: 2017/003/015/601/003

Buhlmann: CALEX® Cap

21 February 2017

IVDs, bacteriology MHRA reference: 2017/003/014/291/003

bioMérieux: NucliSENS® Lysis Buffer

10 March 2017

IVDs, viral microbiology

MHRA reference: 2017/003/010/299/011

C2 Therapeutics: C2 CryoBalloon Focal Ablation System

13 March 2017

Surgical, cryogenic Model: FG-1012

MHRA reference: 2017/003/014/291/018

CareFusion: Biopsy, Aspiration, Bone Marrow needles and kit

9 March 2017

Surgical instruments, minimal access

MHRA reference: 2017/003/013/701/015

Covidien: Covidien Curity™ Sodium Chloride Dressing; Covidien Curity™ Eye Pad Oval

9 March 2017

Basic dressings, absorbents, swabs, procedure packs

MHRA reference: 2017/003/010/291/002

KARL STORZ: FLIPPTACK, Fixations button

15 March 2017

Osteosynthesis, bone screws

Model: 28729FT

MHRA reference: 2017/003/015/701/011

Medtronic: Medtronic StrataMR™ Adjustable Valves & Shunts

March 2017

Implants, non-active, hydrocephalus shunts

Model: Valves and Shunts: 42955, 42965, 46955, 46960, 46965, and 46970 Adjustment Tools: 45905

MHRA reference: 2017/003/009/291/021

Merit Medical: PreludeSYNC™ Radial Compression Device

1721504-03/03/17-002R

Surgical equipment, tourniquets

MHRA reference: 2017/003/015/291/007

Philips: HeartStart MRx Defibrillator/Monitor

February 2017

Defibrillators, non-implantable

Model: M3535A (M3535ATZ), M3536A (M3536ATZ),

M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

MHRA reference: 2017/003/015/291/022

ROHO: ROHO® HIGH PROFILE® Single Compartment Cushion with Sensor Ready™ Technology; ROHO® MID PROFILE® Single Compartment Cushion with Sensor Ready™ Technology

14 March 2017

Pressure relief cushions

MHRA reference: 2017/003/015/701/013

Siemens: ADVIA Centaur BR 1and 5 Ready Pack Primary Reagent

March 2017

IVDs, clinical chemistry MHRA reference: 2017/003/014/601/002

Stryker: LFIT Anatomic CoCr V40 Femoral Heads

13 March 2017 Joint prosthesis, hip MHRA reference: 2016/009/028/701/006

Thermo Fisher: enGen Laboratory Automation Systems

March 2017 IVDs, clinical chemistry MHRA reference: 2017/003/014/601/001

Verathon Medical: GlideScope GVL 2 Stat

1 March 2017

Airway devices

Model: GVL 2 Stat: 0574-0027 (Single Stat)

MHRA reference: 2017/003/010/291/016

Zimmer: iAssist Validation Tool/SmartTools Knee System

10 March 2017

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2017/003/013/291/008

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