Recalls / —

—#43211

Product

Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 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 # ZIB6-80-7.0-40.

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 1546123.

Why it was recalled

The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.

Recalling firm

Firm

Cook, Inc.

Address

750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern

Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and Canada.

Timeline

Recall initiated

2005-10-24

Posted by FDA

2006-01-13

Terminated

2006-04-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.