Recall Z-0554-03 ยท EZN Dilator, Catheter, Ureteral
Cook Urological, Inc.
Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
| Date | Feb 13, 2003 (initiated Jan 22, 2003) |
| Status | Terminated |
| Reason | Product is labeled sterile, but was not sterilized. |
| Root cause | Other |
| Action | Customers were notified by phone call and recall letter beginning on 1/22/03. |
| Quantity | 15 |
| Distribution | Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C Cook Urological, Inc., Mar 25, 1999 |