Recall Z-0845-2009 ยท FAD Stent, Ureteral
Vance Products Incorporated
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent.
| Date | Jan 23, 2009 (initiated Jul 31, 2008) |
| Status | Terminated |
| Reason | The bond may break where the two materials meet, resulting in separation of the stent. |
| Root cause | Process control |
| Action | Consignees were notified via "Urgent: Recall Notice" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241. |
| Quantity | 1739 of all products. |
| Distribution | Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961446 | AQ HYDROPHILIC STENT Cook Urological, Inc., May 28, 1996 |