Field Safety Notices: 14 to 18 June 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 14 to 18 June 2021.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Activated Alanine Aminotransferase
10 June 2021
IVDs, clinical chemistry
MHRA reference: 2021/006/014/291/002
Abtek Biologicals: 05-OXC1-C Oxacillin 1µg
11 June 2021
IVDs, bacteriology
Model: Antibiotic Sensitivity Disc in cartridge
MHRA reference: 2021/006/011/701/023
Adria: Kits of two cement Injection Cannula 11G X 235 mm and two Sterile Trocard Needles.
7 May 2021
Surgical instruments, minimal access
MHRA reference: 2021/004/014/487/005
Edwards Lifesciences: Pressure Monitoring Set (VAMP Jr.&TruWave/VAMP Jr)
FCA # 164
Blood sample collection equipment
Model: PXVJ0711 / PXVJ356 / T443952B / VMP306PX / VMP406PX / VMP426PX / VJ0990 and VMP306
MHRA reference: 2021/006/014/291/003
Fritz Stephan: EVE IN; TR; NEO
31 May 2021
Lung ventilators
MHRA reference: 2021/006/011/487/017
GE Healthcare: Centricity High Acuity
7 June 2021
Monitors, patient
MHRA reference: 2021/006/008/291/001
Hemodia: INTER TUBING WC-VALVE DF PUMP
9 April 2021
Infusion & transfusion, administration sets
Model: 11010078
MHRA reference: 2021/005/021/701/043
IBA: ProteusPLUS, ONE
10 June 2021
Radiotherapy
Model: 235
MHRA reference: 2021/006/011/487/004
Medline: Flexible light handle cover
1 June 2021/FSN – 21/09
Lamps & lights
MHRA reference: 2021/006/011/487/006
Medline: Tubulure Y irrigation
9 June 2021/FSN – 21/07
Infusion & transfusion, administration sets
MHRA reference: 2021/006/011/487/005
Medtronic: EnVeo R and EnVeo PRO Delivery Catheter
June 2021
Implants, non active, cardiovascular heart valves
MHRA reference: 2021/006/011/487/014
Olympus: Endocuff Vision
15 June 2021
Endoscopes, flexible
Model: ARV110 ENDOCUFF-V M BLUE PK8 & ARV120 ENDOCUFF-V L GREEN PK8 & ARV130 ENDOCUFF-V S PURPLE PK8 & ARV140 ENDOCUFF-V XL ORANGE PK8
MHRA reference: 2021/006/011/601/500
OrganOx: Metra Retained Unit
26 May 2021
Storage & collection devices
Model: D0003
MHRA reference: 2021/006/016/291/001
Philips Respironics: CPAP and Bi-Level PAP Devices
2021-06-A
Lung ventilators
MHRA reference: 2021/006/010/487/007
Philips Respironics: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series
Device Models
2021-05-A
Lung ventilators
MHRA reference: 2021/006/010/487/008
Siemens Healthineers: Atellica UAS 800 Analyzer
May 2021
IVDs, clinical chemistry
Model: SMN# 11065004
MHRA reference: 2021/006/010/601/502
Stago: STA-R MAX
16 June 2021
Coagulation
MHRA reference: 2021/006/018/487/001
SynCardia: Freedom Driver System
4 June 2021/RA-1689
Implantable ventricular assist devices
MHRA reference: 2021/006/007/601/500
SynCardia: Temporary Total Artificial Heart System
28 May 2021/RA-1687
Implantable ventricular assist devices
MHRA reference: 2021/005/029/601/001