Oxygenators recalled after a unit failed carbon dioxide transfer requirements
Medtronic Perfusion Systems is recalling 26 Affinity NT Oxygenators after identifying a unit with decreased CO2 gas transfer rates that did not meet performance requirements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an oxygenator falling short of its gas transfer requirement is a hazard during bypass, and no injuries are reported.
Plain-English summary
The Affinity NT Oxygenator with Balance Biosurface and uncoated cardiotomy/venous reservoir, product number 541B, from Medtronic Perfusion Systems, is being recalled.
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
The recall covers 26 units from lot 231621003, unit serial number 5117755016, carrying UDI-DIs 00763000187842 and 20763000187846. The product was distributed in Arizona, California and Tennessee. The FDA has classified the action as Class II.
An oxygenator that does not clear carbon dioxide at the expected rate matters during cardiopulmonary bypass. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medtronic's instructions.
The recalled product
- Product
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Number: 231621003
- Unit Serial Number: 5117755016
- UDI-DI: 00763000187842
- 20763000187846
Distribution
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