| 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. |
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FDA Determined
Cause 2 | Other |
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| Action | Domestic customers were notified by overnight letter beginning 6/22/2005.Foreign consignees were notified by e-mail on 6/16-17/2005 |
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| 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. |
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| 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
|
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