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U.S. Department of Health and Human Services

Class 2 Device Recall Autotransfusion apparatus

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  Class 2 Device Recall Autotransfusion apparatus see related information
Date Initiated by Firm June 22, 2005
Date Posted August 03, 2005
Recall Status1 Terminated 3 on July 27, 2006
Recall Number Z-1069-05
Recall Event ID 32561
510(K)Number K933625  
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product ASY Brat 2 Procedure Set, for blood recovery & autotransfusion.
Code Information Catalog Number 007213100, Lot Numbers 0511600003, 0512300003, 0513000003, 0513700003, 0514400005
Recalling Firm/
Cobe Cardiovascular, Inc
14401 W 65th Way
Arvada CO 80004-3524
For Additional Information Contact
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 2
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 1002 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 and Original Applicant = COBE CARDIOVASCULAR, INC.