Recall Z-1196-04 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Cook, Inc.
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 18 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-18-37.
| 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.