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