Field Safety Notices: 01 to 05 February 2021
List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 February 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 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
Baxter Healthcare SA: PrisMax, V2, ROW
21 January 2021
Dialysis, Haemofilters
Model: 955558
MHRA reference: 2021/001/022/487/002
BD: BD 1ml Syringe Luer-Lok™ Tip
08 January 2021
Injection Devices
Model: BD 1ml Syringe Luer-Lok™ Tip
MHRA reference: 2020/012/010/487/006
BD: Bodyguard 121 Twins
01 February 2021
Infusion Systems
Model: Bodyguard 121 Twins
MHRA reference: 2021/001/029/291/007
BD: T34 Ambulatory Syringe Pump
05 February 2021
Infusion Systems
Model: T34 Ambulatory Syringe Pump
MHRA reference: 2021/002/003/487/010
CareDx AB: Olerup QTYPE 11
01 February 2021
IVDs, Immunology
Model: Olerup QTYPE 11
MHRA reference: 2021/002/001/701/046
CooperSurgical, Inc.: Milex Gellhorn/Flexible Short-Stem Pessary 2 ¼”
21 January 2021
Implants, Non Active, Implantable Incontinence And Prolapse Devices
Model: MXKPGSS2-1/4; MXPGSS2-1/4
MHRA reference: 2021/002/002/701/001
Medtronic Inc (710): Commercial name/brand name/make Viva™ and Brava™ Cardiac Resynchronization Therapy-Defibrillation (CRT-D) Devices, Evera™ Implantable Cardioverter-Defibrillator (ICD) Devices, Evera MRI SureScan Implantable Cardioverter Defibrillator (ICD) Devices, Visia AF™ and Visia AF MRI™ SureScan™ Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD) Devices, Claria MRI™, Amplia MRI™, Compia MRI™ CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology
02 February 2021
Implants, Active, Cardiac resynchronisation therapy
Model: DDBB1D4, DDBB2D1, DDBB2D4, DDBB2D4G, DDBC3D1, DDBC3D4, DDMB2D1, DDMB2D4, DDMC3D1, DDMC3D4, DTBA1D1, DTBA2D1, DTBA2D4, DTBA2Q1, DTBA2QQ, DTBB2D1, DTBB2D4, DTBB2Q1, DTBB2QQ, DTBC2D1, DTBC2D4, DTBC2Q1, DTBC2QQ, DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQ, DTMB2D1, DTMB2D4, DTMB2Q1, DTMB2QQ, DTMC2D1, DTMC2D4, DTMC2QQ, DVAB2D1, DVAB2D4, DVAC3D1, DVAC3D4, DVBB2D1, DVBB2D4, DVBC3D1, DVBC3D4, DVFB2D1, DVFB2D4, DVFC3D1, DVFC3D4, DVMB2D1, DVMB2D4, DVMC3D1, DVMC3D4
MHRA reference: 2021/002/003/487/009
Mercado Medic AB: REAL 9000, 6100 and 2000 series
04 December 2020
Wheelchairs, Manual
Model: REAL 9000, 6100 and 2000 series
MHRA reference: 2021/002/002/487/001
Merit Medical Systems Inc: HeartSpan(R) Transseptal Needle
27 January 2021
Vascular Cannula/Catheter Accessories
Model: HeartSpan(R) Transseptal Needle
MHRA reference: 2021/002/004/487/013
Micronclean Ltd: MicronDevices Sterile Packs
01 February 2021
Injection Devices
Model: MicronDevices Sterile Packs
MHRA reference: 2021/002/001/601/004