Class 3 Device Recall Medtronic

• Date Initiated by Firm: March 25, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on November 23, 2005
• Recall Number: Z-0815-04
• Recall Event ID: 28638
• 510(K)Number: K936003 K973760
• Product Classification: Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
• Product: Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
• Code Information: Lot 0402000017
• Recalling Firm/ Manufacturer: Medtronic Perfusion Systems; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: Preeti Jain; 763-391-9533
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTZ