| | Class 2 Device Recall Cook ATB Advance PTA Dilatation Catheter |  |
| Date Initiated by Firm | February 28, 2007 |
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| Date Posted | March 29, 2007 |
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| Recall Status1 |
Terminated 3 on May 29, 2007 |
| Recall Number | Z-0665-2007 |
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| Recall Event ID |
37568 |
| 510(K)Number | K052036 |
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| Product Classification |
angioplasty dilatation catheter - Product Code DQY
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| Product | Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0. |
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| Code Information |
Lot 1820419. |
| FEI Number |
1820334
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Recalling Firm/
Manufacturer |
Cook, Inc.
750 Daniels Way
Bloomington
IN
47404-9120
|
| For Additional Information Contact |
800-346-2686 |
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Manufacturer Reason
for Recall | Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified via telephone on 2/28/07 and instructed to return the product. |
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| Quantity in Commerce | 20 units |
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| Distribution | Illinois, North Carolina and South Carolina. |
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| 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 = DQY
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