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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall Howell D.A.S.H. II Direct Access System see related information
Date Initiated by Firm December 17, 2003
Date Posted January 07, 2004
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = WILSON-COOK MEDICAL, INC.
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