FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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, recommen
Brand
Cook, Inc.
UPC
Lot 1546123.

Units Affected

6