—#33491

Product

Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-12-80.

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 1356524, 1356532, 1356519, 1356525, 1356523, 1356522 and 1356529.

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 #33491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.