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Class 2 Device Recall Autotransfusion apparatus |
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Date Initiated by Firm |
June 22, 2005 |
Date Posted |
August 03, 2005 |
Recall Status1 |
Terminated 3 on July 27, 2006 |
Recall Number |
Z-1071-05 |
Recall Event ID |
32561 |
510(K)Number |
K933625
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Product Classification |
Apparatus, Autotransfusion - Product Code CAC
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Product |
ASY Brat 2 Procedure Set |
Code Information |
Catalog Number: 007214100. Lot Numbers 0511600001, 0511600002, 0512300001, 0512300002, 0513000002, 0513000001, 0513700001, 0513700002, 0514400002, 0514400003, 0514400004, 0515100185. |
Recalling Firm/ Manufacturer |
Cobe Cardiovascular, Inc 14401 W 65th Way Arvada CO 80004-3524
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For Additional Information Contact |
303-467-6306
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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.
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FDA Determined Cause 2 |
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 |
6832 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
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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.
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510(K) Database |
510(K)s with Product Code = CAC and Original Applicant = COBE CARDIOVASCULAR, INC.
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