Recall Z-0665-2007 ยท DQY Catheter, Percutaneous
Cook, Inc.
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.
| Date | Mar 29, 2007 (initiated Feb 28, 2007) |
| Status | Terminated |
| Reason | Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0. |
| Root cause | Other |
| Action | Consignees were notified via telephone on 2/28/07 and instructed to return the product. |
| Quantity | 20 units |
| Distribution | Illinois, North Carolina and South Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052036 | ATB ADVANCE PTA DILATATION CATHETER Cook, Inc., Aug 25, 2005 |