Field Safety Notices: 17 - 21August 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 17 August to 21 August 2020.

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

View a list of FSNs published since January 2020

View FSNs since November 2014 FSNs before this date are on the National Archives website

Apollo Endosurgery: LAP-BAND System and Accessories

FSCA-20-001

Implants, non-active, gastrointestinal

Model: C-20360, C-20365, C-20304, C-20306

MHRA reference: 2020/008/013/601/007

ArthroCare (Smith & Nephew): SpeedStitch Needle

17 August 2020

Sutures

MHRA reference: 2020/008/019/487/003

BioMérieux: Chocolat PolyViteX (PVX)

21 August 2020

IVDs, bacteriology

MHRA reference: 2020/008/020/487/005

DTR Medical: TAC2003 Tibbs Arterial Cannula Set of 3 sizes & TAC20LC Tibbs Arterial Cannula Large Cone 48mm Standard

13 August 2020

Vascular cannula and catheters

Model: TAC2003 & TAC20LC

MHRA reference: 2020/008/013/601/005

Intersurgical: AbCan, Spherasorb Disposable CO2 Absorber

21 August 2020

Gas absorbers

MHRA reference: 2020/008/020/487/001

Maquet (Getinge): Heater-Cooler Unit HCU 40

5 August 2020

Blood/fluid warming systems

Model: 70104.4054; 70105.4917

MHRA reference: 2020/008/014/487/012

MedCom Gesellschaft fuer medizinische Bildverarbeitung: Mobile US

22 July 2020

Ultrasound, imaging

Model: 2.1

MHRA reference: 2020/008/019/291/001

Medineering: Surgical Base System

12 August 2020

Surgical navigation system and accessories

Model: Surgical Base System SBS 1.3.2 and SBS 1.4

MHRA reference: 2020/008/012/701/006

Ortho Clinical: ORTHO VISION and VISION Max Analyzers

CL2020-206

IVDs, blood transfusion

Model: 6904579 and 6904578

MHRA reference: 2020/008/017/601/001

Riverpoint Medical: Velosorb Fast Surgical Suture

17 August 2020

Sutures

MHRA reference: 2020/008/007/701/026

Updates to this page

Published 24 August 2020