Health product recall

Affinity Fusion Oxygenators

Brand(s)
Last updated

Summary

Product
Affinity Fusion Oxygenators
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Affinity Fusion Oxygenator - Oxygenator With Integrated Arterial Filter And Balance Biosurface

224893902
224602715

BB811

Medtronic Tubing Pack

More than 10 numbers, contact manufacturer.

BB11P45R9
BB9N38R9
BB11P45R5
BB11X15R1
BB9N38R12

Affinity Fusion Oxygenator With Integrated Arterial Filter And Cortiva Bioactive Surface And Cardiotomy/Venous Reservor With Balance Biosurface

223952969
224448403

CB841

Intersept Custom Tubing Packs

More than 10 numbers, contact manufacturer.

HY9G02R4
HY9M73R2
HY8H57R16

Custom Pack W/Bb Coating

More than 10 numbers, contact manufacturer.

BB8B22R15
BB8B22R14

Affinity Fusion Oxygenator - Oxygenator With Integrated Arterial Filter And Cardiotomy/Venous Reservoir With Balance Biosurface

More than 10 numbers, contact manufacturer.

BB841

Intersept Custom Tubing Packs With Cortiva

224879055
224277409
224033614
223282965

HY11M41R1
M020517G

Medtronic Custom Pack

225181585
223278252
223815950
223808288
224986661
224012635
223815951
223246260
223523171

M020519A
M020506D

Issue

Loose Temperature Monitoring Adapter (TMA) located on the Affinity Fusion Oxygenator either during pre-procedure perfusion set up or post-procedure when disassembling the perfusion circuit.

Recall start date: December 12, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Cardiovascular
Companies

Medtronic Inc.

8200 Coral Sea Street N.E., Mounds View, Minnesota, United States, 55112

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72505

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