—#33900

Product

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 54mm - delivery system 16 FR; Catalog no. TFLE-24-54.

FDA product code: MIH — System, Endovascular Graft, Aortic Aneurysm Treatment
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020018
Affected lot / code info: Lots1372418, 1361968, 1366103, F1564275, F1564132, F1564133, F1564134, F1564276, F1564277, F1565677, F1565678, F1565679, F1571069, F1569295, F1569296, F1575361, F1575362, F1575363 and 1366093.

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 #33900. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.