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

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Baxter Healthcare SA: PrisMax, V2, ROW

21 January 2021

Dialysis, Haemofilters

Model: 955558

MHRA reference:

BD: BD 1ml Syringe Luer-Lok鈩� Tip

08 January 2021

Injection Devices

Model: BD 1ml Syringe Luer-Lok鈩� Tip

MHRA reference:

BD: Bodyguard 121 Twins

01 February 2021

Infusion Systems

Model: Bodyguard 121 Twins

MHRA reference:

BD: T34 Ambulatory Syringe Pump

05 February 2021

Infusion Systems

Model: T34 Ambulatory Syringe Pump

MHRA reference:

CareDx AB: Olerup QTYPE 11

01 February 2021

IVDs, Immunology

Model: Olerup QTYPE 11

MHRA reference:

CooperSurgical, Inc.: Milex Gellhorn/Flexible Short-Stem Pessary 2 录鈥�

21 January 2021

Implants, Non Active, Implantable Incontinence And Prolapse Devices

Model: MXKPGSS2-1/4; MXPGSS2-1/4

MHRA reference:

Medtronic Inc (710): Commercial name/brand name/make Viva鈩� and Brava鈩� Cardiac Resynchronization 皇冠体育apprapy-Defibrillation (CRT-D) Devices, Evera鈩� Implantable Cardioverter-Defibrillator (ICD) Devices, Evera MRI SureScan Implantable Cardioverter Defibrillator (ICD) Devices, Visia AF鈩� and Visia AF MRI鈩� SureScan鈩� Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD) Devices, Claria MRI鈩�, Amplia MRI鈩�, Compia MRI鈩� 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:

Mercado Medic AB: REAL 9000, 6100 and 2000 series

04 December 2020

Wheelchairs, Manual

Model: REAL 9000, 6100 and 2000 series

MHRA reference:

Merit Medical Systems Inc: HeartSpan(R) Transseptal Needle

27 January 2021

Vascular Cannula/Catheter Accessories

Model: HeartSpan(R) Transseptal Needle

MHRA reference:

Micronclean Ltd: MicronDevices Sterile Packs

01 February 2021

Injection Devices

Model: MicronDevices Sterile Packs

MHRA reference:

Updates to this page

Published 8 February 2021