Field Safety Notice - 8 to 12 May 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 8 May - 12 May 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

ArcRoyal: Inflation Device 30 atm

8 May 2017

Vascular cannula/catheter accessories

MHRA reference: 2017/005/010/291/018

Beckman Coulter: UniCel DxH 800/600 Cellular Analysis Systems

3 May 2017

IVDs, haematology

MHRA reference: 2017/005/004/601/015

Bio-Rad: MONOLISA™ HCV Ag-Ab ULTRA V2

24 March 2017

IVDs, viral microbiology

MHRA reference: 2017/005/003/701/046

Convatec: Various Oxygen Masks

10 May 2017

Anaesthetic & breathing, masks

Model: 104MM 106MM 108-E 108MM 3226-E 3226MM 3230MM 9108MM

MHRA reference: 2017/005/009/701/010

Covidien: Polysorb™ Braided Absorbable Suture

Endo Stitch™ Loading Unit with Polysorb™ Suture Maxon™ Monofilament Absorbable Suture Biosyn™ Monofilament Absorbable Suture

09 May 2017

Sutures

MHRA reference: 2017/005/011/291/013

Erbe Elektromedizin: ERGO-Griffstück für BiClamp E LAP-Zange

13 March 2017

Surgical, diathermy

Model: 20195-240, 20195-245

MHRA reference: 2017/005/010/291/003

Gambro

05 May 2017

Dialysis, haemofilters

Model: Prismaflex

MHRA reference: 2015/007/008/401/501

Implant Direct:Legacy Full-Contour Abutment 3.5mmD Assembly

April 2017

Implants, dental

Model: HLA3-5

MHRA reference: 2017/005/003/601/009

LivaNova: Heater-cooler (1T), Heater-cooler 3T, FlexTherm

03 May 2017

Blood/fluid warming systems

Model: 16-02-50, 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85, 16-02-95, 16-70-00

MHRA reference: 2017/005/008/701/012

Samsung: GC80

19 April 2017

X Ray, digital acquisition systems

MHRA reference: 2017/004/013/701/016

Smith & Nephew: BHR Acetabular Cup

4 May 2017

Joint prosthesis, hip

Model: BHR Acetabular Cup

MHRA reference: 2017/005/008/291/013

Molnlycke Health Care: See attached Product Table

3 May 2017

Surgical devices, non-powered

MHRA reference: 2017/005/004/701/029

Monica Healthcare: Monica Novii Wireless Patch System

FMI 32053

Monitors, foetal

MHRA reference: 2017/005/008/299/002

Olympus: HF-resection electrode, loop, 24 Fr., 12°

5 May 2017

Surgical, Diathermy

Model: A22201A (0.35 wire), A22201C (0.35 wire, sterile, single use, 12 pcs.), WA22037C (long, sterile, single use, 12 pcs)

MHRA reference: 2017/004/027/701/010

Randox Laboratories: Liquid Cardiac Control

25 April 2017

IVDs, clinical chemistry

Model: CQ5053

MHRA reference: 2017/005/005/601/010

Rocket Medical: R22610-S

CustComp397

Suction equipment

MHRA reference: 2017/005/005/601/002

Published 15 May 2017