—#32270

Product

Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K936003, K973760
Affected lot / code info: Lot 0402000017

Why it was recalled

An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.

Timeline

Recall initiated: 2004-03-25
Posted by FDA: 2004-07-20
Terminated: 2005-11-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.