Z-0815-04

Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with...

Name: Z-0815-04 Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with...
Creator: Medtronic Perfusion Systems
Published: 2004-03-25
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2004-03-25 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model... on 2004-03-25. The reason FDA records is "An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0815-04
Status: Terminated
Initiated: 2004-03-25
Posted: 2004-07-20
Terminated: 2005-11-23
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 132 units
Distribution: The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.
Product codes and lots: Lot 0402000017

Product code DTZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)