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 FSNs

Abbott: IRIDICA Bead Beater (BB)

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

MHRA reference: 2017/003/029/701/023

Abbott: HeartMate II ® System Controller

29 March 2017

Implantable ventricular assist devices Model: 105109

MHRA reference: 2017/003/030/701/007

Aesculap: Diamond burrs

27 March 2017

Surgical power tools MHRA reference: 2017/003/029/701/012

bioMérieux: ETEST® OX 256 (OXACILLIN)

29 March 2017

IVDs, bacteriology MHRA reference: 2017/003/029/299/023

Cook: See Product List attached

20 March 2017

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

MHRA reference: 2017/003/024/701/014

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

17 March 2017

Vascular cannula and catheters MHRA reference: 2017/003/030/701/009

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

FMI 76164 & 76168 Ultrasound, imaging MHRA reference: 2017/003/029/701/009

GE: Vivid S60 / S70

FMI 76168 Ultrasound, imaging MHRA reference: 2017/003/029/701/017

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

164826 Airway devices MHRA reference: 2017/003/028/299/021

Intuitive Surgical: EndoWrist Stapler Release Kit; Surgical Wrench

23 March 2017

Endoscopes, rigid Model: EndoWrist Stapler Release Kit MHRA reference: 2017/003/023/701/022

LeMaitre Vascular: Hydro LeMaitre® Valvulotome

13 February 2017

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

MHRA reference: 2016/008/009/701/012

Merit Medical: Medallion® syringe

Medallion 1mL syringe recall 2017 Injection devices MHRA reference: 2017/003/029/701/016

Orthos: Wheelchair

24 March 2016

Wheelchairs, manual Model: Drift / Impluse MHRA reference: 2017/001/011/410/001

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

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

MHRA reference: 2017/003/023/701/023

Servicio Integral Hospitalario: Custom Packs that contain LaserEdge® knives

28 March 2017

Surgical devices, non-powered

MHRA reference: 2017/003/020/291/024

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