FDA Device

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.

Hazard

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

What You Should Do

Remedy

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

Products

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 wi
Brand
Cook, Inc.
UPC
Lot 1557057.

Units Affected

5