Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon le
FDA device recall Z-0665-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
- Action taken
- Consignees were notified via telephone on 2/28/07 and instructed to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 20 units
- Distribution
- Illinois, North Carolina and South Carolina.
- Date initiated
- 2007-02-28
- Date posted
- 2007-03-29
- Date terminated
- 2007-05-29
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATB ADVANCE PTA DILATATION CATHETER (K052036) | Cook, Inc. | 2005-08-25 |