Date Initiated by Firm | June 22, 2005 |
Date Posted | August 03, 2005 |
Recall Status1 |
Terminated 3 on July 27, 2006 |
Recall Number | Z-1074-05 |
Recall Event ID |
32561 |
510(K)Number | K933625 |
Product Classification |
Apparatus, Autotransfusion - Product Code CAC
|
Product | ASY, Brat 2 Procedure Set |
Code Information |
Castalog Number:007214901. Lot Numbers 0512300008, 0514400009. |
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 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 | 112 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
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