Recall Z-1162-2007 ยท EZB Stylet For Catheter, Gastro-Urology
Cook Urological, Inc.
Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
| Date | Aug 9, 2007 (initiated Jun 12, 2007) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed. |
| Root cause | Process control |
| Action | Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return. |
| Quantity | 100 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.