—#33861

Product

Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters 11 mm - main body length contralateral limb 132mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-132.

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 F1545891, F1541892, F1553589, F1549244, F1548112, F1560064, F1560065 and F1560066.

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 #33861. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.