Class 2 Device Recall Autotransfusion apparatus

• Date Initiated by Firm: June 22, 2005
• Date Posted: August 03, 2005
• Recall Status: Terminated on July 27, 2006
• Recall Number: Z-1072-05
• Recall Event ID: 32561
• 510(K)Number: K933625
• Product Classification: Apparatus, Autotransfusion - Product Code CAC
• Product: ASY, Brat Pack Procedure Set
• Code Information: Catalog Number: 007214102. Lot numbers 0511600006, 0512300005, 0513000006, 0513700007, 0513700005, 0514400007, 0514400008, 0515100189
• Recalling Firm/ Manufacturer: Cobe Cardiovascular, Inc; 14401 W 65th Way; Arvada CO 80004-3524
• For Additional Information Contact: 303-467-6306
• Manufacturer Reason for Recall: Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
• FDA Determined Cause: Other
• Action: Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005
• Quantity in Commerce: 2912 units
• Distribution: Nationwide, including VA facilities in PA and WA. No other military or government consignees. Foreign distribution to Australia, Canada, Italy and Japan.
• 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 = CAC