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Terminated

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

FDA Recall Z-0815-04 · Posted 2004-07-20

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDTZ
Date Initiated2004-03-25
Date Terminated2005-11-23
Product Quantity132 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973760AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACEAvecor Cardiovascular, Inc. · 1998-02-18K936003AFFINITY CVRAvecor Cardiovascular, Inc. · 1994-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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