Recall Z-1218-04 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook, Inc.
Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only for further processing; ZRB-22-WCE.
| Date | Jul 27, 2004 (initiated Jun 10, 2004) |
| Status | Terminated |
| Reason | Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use. |
| Root cause | Other |
| Action | The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004. |
| Quantity | 12 |
| Distribution | Nationwide, Canada, Denmark and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.