Field safety notices - 15 to 19 February 2016

List of field safety notices (FSNs) from medical device manufacturers from 15 February to 19 February 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

Bard

FA2015-52

Surgical iInstruments, minimal access

Model: Bard TruGuide® Disposable Coaxial Biopsy Needle, C2016B

MHRA reference: 2016/002/015/601/005

Becton, Dickinson & Company: BD Surepath Preservative Collection Vial

15 February 2016.

IVDs, cytopathology & histopathology

Model: 490527; 490505; 491288

MHRA reference: 2016/002/016/601/008

Caesarea Medical Electronics: CME BodyGuard Infusion Sets

09 February 2016

Infusion & transfusion, administration sets

Model: 120-112XSFV, 100-163XESK, 120-112XSFK, 100-163XE90SK,

MHRA reference : 2016/002/017/291/001

Eli Lilly and Company: Filter kit provided free of charge with ReoPro

12 February 2015

Infusion & transfusion, administration sets

MHRA reference: 2016/002/015/292/011

GE Healthcare Life Sciences: Carestation 620 A1 / 650 A1 / 650c A1

FMI34074 Anaesthetic machines & monitors MHRA reference: 2016/002/011/292/002

RaySearch Laboratories

9397 Radiotherapy planning and verification systems Model: 3.0, 3.5, 4.0, 4.5 and 4.7

MHRA reference: 2016/002/012/701/010

Teleflex: Hem-o-lok Auto Endo5 Medium Large Ligating Clip Applier

12 February 2016

Endoscopic single clip applier

Model: 543965, WK543965

MHRA reference: 2016/002/015/291/007

Verathon Medical: GlideScope® Video Laryngoscope Titanium SU blades

09 February 2016

Airway devices MHRA reference: 2016/002/015/291/002

Verathon Medical:

09 February 2016

Airway devices

Model: LoPro S3: 0574-0130 (single blade), LoPro S4: 0574-0131 (single blade), MAC S3: 0574-0132 (single blade), MAC S4: 0574-0133 (single blade)

MHRA reference: 2016/002/012/292/007

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