FDA Device

Howell D.A.S.H. II Access System, Wire Guided Sphincterotome

Hazard

Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.

What You Should Do

Remedy

Consignees were notified by letter sent via Certified Mail on December 17, 2003.

Products

Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
Brand
Wilson-Cook Medical Inc
UPC
Reorder Number: DASH-35-480, Lot Number: W1815864

Units Affected

18 units