Recall Z-0368-06 ยท KRD Device, Vascular, For Promoting Embolization
Cook, Inc.
Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
| Date | Jan 10, 2006 (initiated Sep 26, 2005) |
| Status | Terminated |
| Reason | The coil is 20 centimeters in length, but the label states the length is 20 millimeters. |
| Root cause | Other |
| Action | Consignees were notified via telephone and recall letter dated September 26, 2005. |
| Quantity | 242 |
| Distribution | Delaware, New York and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.