Recall Z-0966-2011 ยท KOD Catheter, Urological
Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
| Date | Jan 25, 2011 (initiated Dec 13, 2010) |
| Status | Terminated |
| Reason | The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch. |
| Root cause | Packaging process control |
| Action | The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product. |
| Quantity | 25 stents |
| Distribution | CA, CT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820313 | VPI-FAIR URETHRAL STENT Vance Products, Inc., Mar 1, 1982 |