Class 3 Device Recall Howell D.A.S.H. II Direct Access System

• Date Initiated by Firm: December 17, 2003
• Date Posted: January 07, 2004
• Recall Status: Terminated on April 16, 2004
• Recall Number: Z-0301-04
• Recall Event ID: 27958
• 510(K)Number: K901443
• Product Classification: Unit, Electrosurgical, Endoscopic (With Or Without Accessories) - Product Code KNS
• Product: Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
• Code Information: Reorder Number: DASH-35-480, Lot Number: W1815864
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc; 5951 Grassy Creek Blvd; Winston Salem NC 27105-1206
• For Additional Information Contact: Jessica Hughes; 336-744-0157
• Manufacturer Reason for Recall: Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
• FDA Determined Cause: Process control
• Action: Consignees were notified by letter sent via Certified Mail on December 17, 2003.
• Quantity in Commerce: 18 units
• Distribution: Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNS