—#44388

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 # ZIB6-80-8.0-40.

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 1557057.

Why it was recalled

The side of the boxes give incorrect sizes for these stents. The label front is correct.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent.

Recalling firm

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

Distribution

Distribution pattern: California, Pennsylvania, Utah and Canada.

Timeline

Recall initiated: 2006-01-26
Posted by FDA: 2006-03-09
Terminated: 2006-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.