Field Safety Notices: 8 to 12 February 2021
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 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
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: 2021/002/011/487/006
Abbott: CPS DirectTM PL Peelable Outer Guide Catheter
8 February 2021
Vascular Cannula and Catheters
Model: 410211, 410210
MHRA reference: 2021/002/011/487/001
Acumed: Olecranon Plate & Locking Medial Plate
14 January 2021 / R21-001
Plate
Model: 70-0312-S, PL-LEM9L-S
MHRA reference: 2021/002/009/701/061
Aseptic Medical Devices: Sterile Transfer Sets & Accessories
4 February 2021 / FSCA-Identifier – 2021/01
Surgical devices, non-powered
Model: Sterile Transfer Sets and Accessories
MHRA reference: 2021/002/011/601/006
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: 2021/002/005/487/005
Cardinal Health: Isolation Gown
7 January 2021 / Event-2020-03230
Surgical Drapes, Gowns, Masks
Model: Cardinal Health™ Device: Isolation Gown
MHRA reference: 2021/002/001/701/045
Getinge: Heater-Cooler Unit HCU 40
5 February 2021 / FSCA-2021-0203
Blood/Fluid Warming Systems
Model: 70104.4054; 70105.4917
MHRA reference: 2021/002/008/487/007
iMDsoft: MetaVision
27 January 2021 / FSN MetaVision Suite
Software as a Medical Device (SaMD)
Model: MetaVision
MHRA reference: 2021/002/003/487/011
Intersurgical: CIRRUS2 NEBULISER, ADULT, ECOLITE MA
11 February 2021 / 1453015
Nebulizer Mask
Model: CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA
MHRA reference: 2020/012/016/487/003
Medline: BD Syringes and Needles
30 January 2021 / FSN-21/01
Injection Devices
Model: BD Syringes and Needles
MHRA reference: 2021/002/011/487/005
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™ CVR: BBP241 Perfusion Tubing Packs built with the affected Affinity
Pixie™ CVR: BB10H89R4, BB7W03R8, HY10J00R6, HY11B40R1, M448036B, M483203D, M484901D, M490817B
MHRA reference: 2021/002/005/487/004
Microbiologics: KWIK-STIK™ 0318P & Comprehensive QC Sets 5190P
24 September 2020 / 2020003
IVDs, Bacteriology
Model: Clostridium perfringens derived from ATCC® 13124™,
Cat. No. 0318P & Comprehensive QC Set, Cat. No. 5190P
MHRA reference: 2021/002/011/487/002
Miltenyi Biotec: CryoMACS Freezing Bag 750
2 February 2021 / FSN EU-Complaint-002716
Cryocyte Storage Bag
Model: 200-074-403
MHRA reference: 2021/001/029/261/001
Molnlycke Health Care: Procedure Trays
26 January 2021 / FSN 2021-01(02)
Surgical devices, non-powered
Model: Mölnlycke® Procedure Trays
MHRA reference: 2021/001/026/291/002
IMI: Humidifier
15 January 2021 / PMFSN0005
Humidifiers
Model: PMH7000 series Heated humidifiers
MHRA reference: 2020/005/021/222/001
Partners for Endoscopy: ScopeFlow Water Bottle Tubing
8 February 2021
Endoscopes, Flexible
Model: ScopeFlow
MHRA reference: 2021/002/008/601/004
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: 2021/002/008/487/005
Siemens Healthcare: ACUSON SEQUOIA Diagnostic Ultrasound System
February 2021/ VA11A
Ultrasound System
Model: 11148775
MHRA reference: 2021/002/009/601/008
Siemens Healthcare: Sensis, Sensis Vibe Combo, Sensis Vibe Hemo
January 2021 / AX009/21/S
Monitor
Model: 10764561, 11007642, 11007641
MHRA reference: 2021/001/028/601/004
Steripack: Urine collection pack
28 August 2020 / 2020FSN_310019_28Aug2020
Urine collection pack
Model: Urine collection pack
MHRA reference: 2021/002/011/487/003
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: 2021/002/010/487/002
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: 2021/002/004/487/012
Xiros: CC Hook Right
9 February 2021 / 2021-001
Anchor
Model: 202-1413
MHRA reference: 2021/002/009/601/005