FDA Device

Spiral Z Expandable Metal Biliary Stent

Hazard

The inner catheter of the introducer system may break after stent deployment.

What You Should Do

Remedy

Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.

Products

Spiral Z Expandable Metal Biliary Stent
Brand
Wilson-Cook Medical Inc
UPC
Reorder #SZBS-10-7.5-C, Amended 8/8/2003 to include SZBS-10-5.7-C

Units Affected

23 units