—#33858

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 lengths contralateral limb 103mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-26-103.

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 F1537433, F1538051, F1538050, F1538052, F1537432, F1542776, F1543318, F1542777, F1538643, F1538644, F1546894, F1543317, F1548659, F1548660, F1546893, F1560057, F1548661, F1545886, F1543316, F1560056, F1538645, F1560059, F1559970, F1565072, F1560063, F1562087, F1565073, F1565074, F1562110, F1562111, F1562088, F1567226, F1560060, F1560061, F1568421, F1568422, F1570156, F1567227, F1567228, F1567229, F1560062, F1571602, F1571603 and F1571601.

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 #33858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.