Field Safety Notices: 8 to 12 March 2021
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 March 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
Accuray: CyberKnife Treatment Delivery System
26 February 2021
Radiotherapy
Model: CyberKnife treatment delivery system
MHRA reference: 2021/003/008/487/012
B Braun: Univation X System
04 March 2021
Joint prosthesis, knee
Model: NO156K, NO157K, NO158K, NO159K, NO160K, NO161K, NO162K, NO163K, NO164K, NO165K, NO166K, NO167K, NO168K, NO169K, NO170K, NO171K, NO172K, NO173K, NO174K, NO175K, NO176K, NO177K, NO178K, NO179K, NO180K, NO181K, NO182K, NO183K, NO184K, NO185K, NO186K, NO187K, NO188K, NO189K, NO190K, NO191K, NO192K, NO193K, NO194K, NO195K, NO196K, NO197K, NO198K, NO199K, NO156Z, NO157Z, NO158Z, NO159Z, NO160Z, NO161Z, NO162Z, NO163Z, NO164Z, NO165Z, NO166Z, NO167Z, NO168Z, NO169Z, NO170Z, NO171Z, NO172Z, NO173Z, NO174Z, NO175Z, NO176Z, NO177Z, NO178Z, NO179Z, NO180Z, NO181Z, NO182Z, NO183Z, NO184Z, NO185Z, NO186Z, NO187Z, NO188Z, NO189Z, NO190Z, NO191Z, NO192Z, NO193Z, NO194Z, NO195Z, NO196Z, NO197Z, NO198Z, NO199Z, NO156K, NO157K, NO158K, NO159K, NO160K, NO161K, NO162K, NO163K, NO164K, NO165K, NO166K, NO167K, NO168K, NO169K, NO170K, NO171K, NO172K, NO173K, NO174K, NO175K, NO176K, NO177K, NO178K, NO179K, NO180K, NO181K, NO182K, NO183K, NO184K, NO185K, NO186K, NO187K, NO188K, NO189K, NO190K, NO191K, NO192K, NO193K, NO194K, NO195K, NO196K, NO197K, NO198K, NO199K, NO156Z, NO157Z, NO158Z, NO159Z, NO160Z, NO161Z, NO162Z, NO163Z, NO164Z, NO165Z, NO166Z, NO167Z, NO168Z, NO169Z, NO170Z, NO171Z, NO172Z, NO173Z, NO174Z, NO175Z, NO176Z, NO177Z
MHRA reference: 2021/003/005/601/003
B.Braun: HISTOACRYL BLUE / LAPFIX / PROSET OFX
08 March 2021
Adhesive control devices
Model: 1050044, 1050052
MHRA reference:2021/003/009/601/001
This original Field Safety Notice (FSN) has been updated by FSNs dated 15 March 2021 and 27 April 2021 which include different models and batch numbers.
Please note the FSN dated 15 March originally contained a typographical error referring to an FSN of 3 March. This has been amended by the manufacturer and now correctly refers to the FSN dated 8th March.
Baxter: COLLEAGUE SINGLE CHANNEL CXE, COLLEAGUE SINGLE CHANNEL MONO, COLLEAGUE TRIPLE CHANNEL CXE, COLLEAGUE TRIPLE CHANNEL MONO
15 March 2021
Infusion systems
Model: 2M91617, 2M81517, 2M81517K, 2M91637, 2M81537K
MHRA reference: 2021/003/010/487/006
BD: Infusion Sets for Alaris Pumps and Gravity Infusion sets and connectors
10 March 2021
Infusion & transfusion, administration sets
Model: GP, VP, CC, GW/GW800 and SE, IVAC 590 series, Gravity
MHRA reference:2021/003/009/291/003
Biotronik: ICD and CRT-D devices
March 2021
Implants, active, defibrillators
Model: Idova, Iforia, Ilesto/Inventra, Iperia, Itrevia/Ilivia, Inlexa, Intica/Ilivia Neo, Intica Neo ICDs and CRT-Ds
MHRA reference: 2021/003/003/487/002
COOK Medical: Bander Ureteral Diversion Stent Set
08 March 2021
Implants, non active, non vascular stents
Model: 025227
MHRA reference: 2021/003/011/487/004
EBR Systems: WiSE CRT Transmitter
03 March 2021
Implants, active, intracardiac (leadless)
Model: 4100
MHRA reference: 2021/003/003/701/049
Ferring Pharmaceuticals:ZomaJet Injector Device for Zomacton (somatropin)
05 March 2021
Injection devices
Model: ZomaJet 10, ZomaJet 2 Vision, ZomaJet Vision X
MHRA reference: 2021/002/018/701/047
LumiraDx: SARS-CoV-2 Ag Test Strip Kit
02 March 2021
IVDs, SARS-CoV-2 Instrumentation antigen test
Model:L016000101048, 5000275 (GM2000220), 5000243 (GM2000195), 5000263 (GM2000212), 5000265 (GM2000218)
MHRA reference: 2021/002/018/601/006
Medline: OPS Essential Gowns
01 March 2021
Surgical drapes, gowns, masks
Model: S3510P-19MAE507, S3540P-19MAE507, S3500P-19MAE498
MHRA reference: 2021/003/008/487/010
Medtronic:Bravo System
March 2021
Implants, active, monitors and recorders
Model: FGS-0312, FGS-0313, FGS-0635, FGS-0636
MHRA reference: 2021/003/009/291/001
Natus: RetCam Envision
03 March 2021
Optometry equipment
Model: RetCam Envision Lens (60-000090)
MHRA reference: 2021/002/026/291/011
Roche Diagnostics: Elecsys CA 19-9
February 2021
IVDs, Clinical Chemistry
Model: 07027028 190
MHRA reference: 2021/003/011/487/008
WEINMANN Medical Technology: MEDUMAT Transport
February 2021
Lung ventilators
Model: WM 28300 and WM 28400
MHRA reference: 2021/003/008/487/009