Class 3 Device Recall Four Shooter Saeed MultiBand Ligator

• Date Initiated by Firm: January 15, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 14, 2004
• Recall Number: Z-0536-04
• Recall Event ID: 28200
• 510(K)Number: K944220
• Product Classification: Ligator, Hemorrhoidal - Product Code FHN
• Product: Four Shooter Saeed Multi-Band Ligator
• Code Information: Reorder/Catalog number MBL-4-XL, Lot W1842922
• 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: Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
• FDA Determined Cause: Other
• Action: Consignee was notified by letter, hand delivered by Cook sales representative on 1/19/2004.
• Quantity in Commerce: 3 units
• Distribution: All units were shipped to one medical facility in CA
• 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 = FHN and Original Applicant = WILSON-COOK MEDICAL, INC.