Recall Z-1168-2007 ยท FAD Stent, Ureteral
Vance Products Incorporated
Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
| Date | Jun 29, 2007 |
| Status | Terminated |
| Reason | The radiographic band may detach from the stent and remain in the patient after removal of the stent. |
| Root cause | Other |
| Action | Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization. |
| Quantity | 75 |
| Distribution | Worldwide, including USA, Canada, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.