Field Safety Notice - 12 to 16 March 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 March 2018

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

Abbott: Alinity hq Analyzer

23 February 2018

IVDs, haematology

MHRA reference: 2018/003/002/478/016

Arjo: Maxi Sky 2 - scales 700-19490 and 700-19485

28 February 2018

Hoists and slings

Model: Product code: 700-19485 & 700-19490

MHRA reference: 2018/002/008/601/001

Biomet Orthopedics (Zimmer): Bone Cement

22 January 2018

Bone cement and tools

MHRA reference: 2017/011/015/291/035

CIVCO Medical Instruments: Infiniti Bracket

26 February 2018

Surgical instruments, minimal access

Model: 639-026, 698-009, 698-016, 620-116

MHRA reference: 2018/003/009/478/013

DiaMed (BioRad): IH-1000

13 March 2018

IVDs, blood transfusion

001000

MHRA reference: 2018/003/015/228/005

Fresenius Kabi: VLST00 standard

15 March 2018

Infusion & transfusion, administration sets

MHRA reference: 2018/001/024/401/006

Gambro Dialysatoren (Baxter): U9000

March 2018

Dialysis, haemodialysis

Model: 112062

MHRA reference: 2018/003/013/478/002

Halyard Health: Halyard* Closed Suction System

07 February 2018

Suction equipment

MHRA reference: 2018/003/009/478/014

MICREL MEDICAL DEVICES SA: RYTHMIC EVOLUTION

12 March 2018

Infusion systems

MHRA reference: 2018/003/014/478/014

Maquet Critical Care AB: Servo-i, Servo-s, Servo-u, Servo-n, Servo-air

27 February 2018

Lung ventilators

Model: 6487800, 6640440, 6694800, 6688600, 6882000, 6884905

MHRA reference: 2018/003/008/478/003

Maquet Getinge Group: OTESUS OR table column, mobile

14 March 2018

Operating table

116001C0, 116001D0

MHRA reference: 2018/003/015/228/004

Micro Therapeutics, lnc. DBA ev3 Neurovascular: MindFrame CaptureTM LP

March 2018

Infusion & transfusion, administration sets

Model: 300010, 300011, 300012, 300013

MHRA reference: 2018/003/012/478/003

Preservation Solutions: Belzer UW Cold Storage Solution 2 Liter

09 March 2018

Storage & collection devices

MHRA reference: 2018/003/009/601/019

Radiometer: TCM5 FLEX/TCM5 BASIC

March 2018

Diagnostic measurement and monitoring

MHRA reference: 2017/010/012/291/008

Rocialle: Vascular Insertian Pack

09 March 2018

Surgical devices, non-powered

MHRA reference: 2018/003/013/228/014

Smith & Nephew: PERI-LOC K-WIRE 1.6MM X 150MM LENGTH TROCAR POINT

09 March 2018

Surgical instruments, minimal access

MHRA reference: 2018/003/014/478/016

Stryker: T5 Toga

March 2018

Surgical mask

MHRA reference: 2018/003/012/478/006

Torbay Pharmaceuticals: Sterile Eye Dropper

12 March 2018

Surgical devices, non-powered

U5134G

MHRA reference: 2018/003/006/601/003

Published 20 March 2018