Recall Z-0377-2007 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Cook Urological, Inc.
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
| Date | Jan 25, 2007 (initiated Jan 5, 2007) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, as the packages may not have been sealed. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 1/5/07 and requested to return the product. |
| Quantity | 4 |
| Distribution | Massachusetts, Maine, New Hampshire and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH Cook Urological, Inc., Mar 31, 2005 |