Field Safety Notice - 27 March to 31 March 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 27 - 31 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

Abbott: IRIDICA Bead Beater (BB)

FA-AM-MAR2017-218 -29 March 2017 IVDs, bacteriology

MHRA reference:

Abbott: HeartMate II 庐 System Controller

29 March 2017

Implantable ventricular assist devices Model: 105109

MHRA reference:

Aesculap: Diamond burrs

27 March 2017

Surgical power tools MHRA reference:

bioM茅rieux: ETEST庐 OX 256 (OXACILLIN)

29 March 2017

IVDs, bacteriology MHRA reference:

Cook: See Product List attached

20 March 2017

Urinary catheters and accessories Model: Bush DL鈩� Ureteral Illuminating Catheter Set, Bush SL鈩� Ureteral Illuminating Catheter Set

MHRA reference:

Cook: Check-Flo庐 Hemostatic Device with Blue Valve Recall Extension

17 March 2017

Vascular cannula and catheters MHRA reference:

GE: Vivid E80 / E90 / E95 / S60N / S70N

FMI 76164 & 76168 Ultrasound, imaging MHRA reference:

GE: Vivid S60 / S70

FMI 76168 Ultrasound, imaging MHRA reference:

Intersurgical: F Solus, Flexible wire reinforced laryngeal mask, sizes 2, 3, 4 and 5

164826 Airway devices MHRA reference:

Intuitive Surgical: EndoWrist Stapler Release Kit; Surgical Wrench

23 March 2017

Endoscopes, rigid Model: EndoWrist Stapler Release Kit MHRA reference:

LeMaitre Vascular: Hydro LeMaitre庐 Valvulotome

13 February 2017

Surgical instruments, non-articulated cutting Model: 1009-00, 1009-00J

MHRA reference:

Merit Medical: Medallion庐 syringe

Medallion 1mL syringe recall 2017 Injection devices MHRA reference:

Orthos: Wheelchair

24 March 2016

Wheelchairs, manual Model: Drift / Impluse MHRA reference:

Richard-Allan Scientific: Shandon Rapid Chrome Kwik-Diff (Kit)

UK RAS KD #17 IVDs, cytopathology & histopathology Model: Assay/ Reagent

MHRA reference:

Servicio Integral Hospitalario: Custom Packs that contain LaserEdge庐 knives

28 March 2017

Surgical devices, non-powered

MHRA reference:

Updates to this page

Published 3 April 2017