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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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Abbott: Alinity i HIV Ag/Ab Combo Calibrator

9 February 2021 / FA09FEB2021

IVDs, Clinical Chemistry

Model: Alinity i HIV Ag/Ab Combo Calibrator

MHRA reference:

Abbott: CPS DirectTM PL Peelable Outer Guide Catheter

8 February 2021

Vascular Cannula and Catheters

Model: 410211, 410210

MHRA reference:

Acumed: Olecranon Plate & Locking Medial Plate

14 January 2021 / R21-001

Plate

Model: 70-0312-S, PL-LEM9L-S

MHRA reference:

Aseptic Medical Devices: Sterile Transfer Sets & Accessories

4 February 2021 / FSCA-Identifier 鈥� 2021/01

Surgical devices, non-powered

Model: Sterile Transfer Sets and Accessories

MHRA reference:

Boston Scientific: 4G LATITUDE MIMIC Cell Adapter 6227

4 February 2021 / FSN 92659146-FA

Telemetry System

Model: 4G LATITUDE MIMIC Cell Adapter 6227

MHRA reference:

Cardinal Health: Isolation Gown

7 January 2021 / Event-2020-03230

Surgical Drapes, Gowns, Masks

Model: Cardinal Health鈩� Device: Isolation Gown

MHRA reference:

Getinge: Heater-Cooler Unit HCU 40

5 February 2021 / FSCA-2021-0203

Blood/Fluid Warming Systems

Model: 70104.4054; 70105.4917

MHRA reference:

iMDsoft: MetaVision

27 January 2021 / FSN MetaVision Suite

Software as a Medical Device (SaMD)

Model: MetaVision

MHRA reference:

Intersurgical: CIRRUS2 NEBULISER, ADULT, ECOLITE MA

11 February 2021 / 1453015

Nebulizer Mask

Model: CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA

MHRA reference:

Medline: BD Syringes and Needles

30 January 2021 / FSN-21/01

Injection Devices

Model: BD Syringes and Needles

MHRA reference:

Medtronic: Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir

(CVR) with Balance Biosurface Perfusion Tubing Pack

February 2021 / FA955

Oxygenator Membrane

Model: Affinity Pixie鈩� CVR: BBP241 Perfusion Tubing Packs built with the affected Affinity

Pixie鈩� CVR: BB10H89R4, BB7W03R8, HY10J00R6, HY11B40R1, M448036B, M483203D, M484901D, M490817B

MHRA reference:

Microbiologics: KWIK-STIK鈩� 0318P & Comprehensive QC Sets 5190P

24 September 2020 / 2020003

IVDs, Bacteriology

Model: Clostridium perfringens derived from ATCC庐 13124鈩�,

Cat. No. 0318P & Comprehensive QC Set, Cat. No. 5190P

MHRA reference:

Miltenyi Biotec: CryoMACS Freezing Bag 750

2 February 2021 / FSN EU-Complaint-002716

Cryocyte Storage Bag

Model: 200-074-403

MHRA reference:

Molnlycke Health Care: Procedure Trays

26 January 2021 / FSN 2021-01(02)

Surgical devices, non-powered

Model: M枚lnlycke庐 Procedure Trays

MHRA reference:

IMI: Humidifier

15 January 2021 / PMFSN0005

Humidifiers

Model: PMH7000 series Heated humidifiers

MHRA reference:

Partners for Endoscopy: ScopeFlow Water Bottle Tubing

8 February 2021

Endoscopes, Flexible

Model: ScopeFlow

MHRA reference:

RaySearch Laboratories: RayStation

22 January 2021 / #73474

Radiotherapy Planning And Verification Systems

Model: RayStation 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B

MHRA reference:

Siemens Healthcare: ACUSON SEQUOIA Diagnostic Ultrasound System

February 2021/ VA11A

Ultrasound System

Model: 11148775

MHRA reference:

Siemens Healthcare: Sensis, Sensis Vibe Combo, Sensis Vibe Hemo

January 2021 / AX009/21/S

Monitor

Model: 10764561, 11007642, 11007641

MHRA reference:

Steripack: Urine collection pack

28 August 2020 / 2020FSN_310019_28Aug2020

Urine collection pack

Model: Urine collection pack

MHRA reference:

Steripack: Syringes with Sodium Chloride 0.9%

5 February 2021 / _09%NaCIPFS_UK_05Feb02021

Catheter Patency Solution

Model: Syringes with Sodium Chloride 0.9%

MHRA reference:

Three Lions: Timesco Single Use Resuscitator (PVC) 29

January 2021 / FSN 20210112

Bag Valve Mask/Pulmonary resuscitator

Model: Timesco Single Use Resuscitator (PVC)

MHRA reference:

Xiros: CC Hook Right

9 February 2021 / 2021-001

Anchor

Model: 202-1413

MHRA reference: