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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