—#48568

Product

Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K051124
Affected lot / code info: Lot 1722922.

Why it was recalled

The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via telephone on 9/21/06 and requested to return the recalled product.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of Canada

Timeline

Recall initiated: 2006-09-21
Posted by FDA: 2006-10-28
Terminated: 2007-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.