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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