—#33883

Product

Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 16 mm - usable length 37mm - delivery system 14 FR; Catalog no. TFLE-16-37.

FDA product code: MIH — System, Endovascular Graft, Aortic Aneurysm Treatment
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020018
Affected lot / code info: Lots 1374872, 1367891, 1367891, 1360460, 1367892, F1561397, F1561398, F1561399, F1561400, F1561401, F1564235, F1564232, F1564233, F1564234, F1564236, F1564168, F1564169, F1565714, F1565715, F1567297, F1567296, F1569275, F1569276, F1569248, F1569249, F1569250, F1572975, F1572976, F1572977, F1572978, F1572979, F1575314, F1575315, F1575317, F1575318, 1367891and 1370819.

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 #33883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.