Medtronic Perfusion Systems Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
Lot 0402000017
Products Sold
Lot 0402000017
Medtronic Perfusion Systems is recalling Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir w due to An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.
Recommended Action
Per FDA guidance
A notification letter, sent on March 25, 2004, requested that consignees complete and return an enclosed certificate which gives the consignee the option of keeping the product or returning it to the firm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026