FDA Device

Biliary Stent Introducer Set

Hazard

The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.

What You Should Do

Remedy

Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .

Products

Biliary Stent Introducer Set
Brand
Wilson-Cook Medical Inc
UPC
Reorder (catalog) number SIS-10, Lot number W1733880

Units Affected

23 pieces