Recall Z-0852-2011 ยท FAD Stent, Ureteral
Vance Products Incorporated
Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder.
| Date | Jan 5, 2011 (initiated Oct 18, 2010) |
| Status | Terminated |
| Reason | The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong. |
| Root cause | Packaging |
| Action | The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product. |
| Quantity | 25 units |
| Distribution | Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961446 | AQ HYDROPHILIC STENT Cook Urological, Inc., May 28, 1996 |