—#33910

Product

Cook brand Zenith rupture main body graft, preloaded graft measuring 26 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-26-WCE.

FDA product code: MIH — System, Endovascular Graft, Aortic Aneurysm Treatment
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Lots F1544276, F1544277, F1544279, F1544280, F1544278, F1554515, F1554516, F1554517, F1554518, F1554519, F1554520, F1554521, F1554523, F1554524, F1554525, F1554522, F1554526, F1554527 and F1554528.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Nationwide, Canada, Denmark and Japan.

Timeline

Recall initiated: 2004-06-10
Posted by FDA: 2004-07-27
Terminated: 2004-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33910. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.