Field safety notices - 7 November - 11 November 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 7 November -11 November 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

Bausch + Lomb: EasySept Hydro Plus Peroxide Solution

28 October 2016

Contact lenses, care products

Model: EasySept Hydro Plus

MHRA reference: 2016/010/028/291/015

Compression Works: AAJT Abdominal Aortic Junctional Tourniquet

7 November 2016

Surgical equipment, tourniquets

Model: 63000

MHRA reference: 2016/011/007/601/005

Concert Medical: Galeo Pro Coronary Guide Wire

9 November 2016

Vascular cannula/catheter accessories

Model: Galeo Pro Coronary Guide Wire; 389781, 389782, 389783, 389784, 389785, 389786, 389787, 389788, 389791.

MHRA reference: 2016/011/008/601/020

Draeger: Infinity Acute Care System (M540)

October 2016

Monitors, patient

Model: MS25510, MS25520, MS26372

MHRA reference: 2016/011/008/291/003

EKF-diagnostic: Quo-Test HbA1c Analyzer

26 May 2016

Quo-Test HbA1c Analyzer

Model: 0108

MHRA reference: 2016/010/011/701/012

Exactech: Equinoxe Reverse Shoulder Defining Screw Kit

17 October 2016

Joint prosthesis, shoulder

Model: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

MHRA reference: 2016/011/004/701/024

Gyrus ACMI: Port Seal and Y-Connector

1 November 2016

Endoscopes, flexible

Model: AUR-BP, UBP-Y

MHRA reference: 2016/011/004/601/011

Mako Surgical: Offset Cup Reamer Handle

17 October 2016

Surgical power tools

Model: Offset Cup Reamer Handle

MHRA reference: 2016/011/004/291/006

Mathys: balanSys UNI convex PE inlays x/5

8 November 2016

Joint prosthesis, knee

Model: 77.30.0211; 77.30.0221; 77.30.0231; 77.30.0241; 77.30.0251

MHRA reference: 2016/011/009/071/001

Maxilabs: Sodium Bicarbonate ear drops 10ml

9 November 2016

Substances for topical application (non-pharmaceutical)

Model: Ear wax softener

MHRA reference: 2016/011/008/291/001

MED-EL: SONNET Mini Battery Pack Cable

27 October 2016

Implants, active, hearing

MHRA reference: 2016/010/028/701/014

Radiometer Medical: PICO70

FAN 915-352

Storage and collection devices

MHRA reference: 2016/011/009/701/014

Siemens: IMMULITE 2000/IMMULITE 2000XPi PSA

4 November 2016

IVDs, clinical chemistry

Model: please see additional information

MHRA reference: 2016/011/003/601/014

Spiggle & Theis Medizintechnik: Inflation device

19 Feburary 2016

Vascular cannula and catheters

Model: 2080-9030020

MHRA reference: 2016/009/007/701/011

Teleflex:

7 November 2016

Surgical instruments, minimal access Model: ARROW® OnControl® Bone Lesion Biopsy System Tray, ARROW® OnControl® Aspiration System Tray, ARROW® OnControl® Bone Lesion Biopsy System Tray, ARROW® OnControl® Bone Lesion Biopsy System Trays

ARROW® OnControl® Bone Marrow Biopsy System Comprehensive Tray, ARROW® OnControl® Bone Marrow Biopsy System Tray, ARROW® OnControl® Ported Aspiration System Tray, ARROW® OnControl® System Sterile Procedure Tray, OnControl® Biopsy System Ported Needle Tray

MHRA reference: 2016/011/008/299/007

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