Recall Z-0980-2009 ยท FAD Stent, Ureteral
Vance Products Incorporated
Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. The ureteral stent is used for temporary dra
| Date | Feb 10, 2009 (initiated Nov 10, 2008) |
| Status | Terminated |
| Reason | "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS. |
| Quantity | 23 |
| Distribution | Nationwide Distribution including states of Georgia, Oregon and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961446 | AQ HYDROPHILIC STENT Cook Urological, Inc., May 28, 1996 |