Class 2 Device Recall

• Date Initiated by Firm: January 30, 2003
• Date Posted: August 26, 2004
• Recall Status: Terminated on March 04, 2005
• Recall Number: Z-1410-04
• Recall Event ID: 29853
• 510(K)Number: K920218
• Product Classification: Prosthesis, Esophageal - Product Code ESW
• Product: Esophageal Z-Stent¿ Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable ¿ Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
• Code Information: Order Number EZSP-25-10-FC, Lot Number R1688574
• 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: Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
• FDA Determined Cause: Other
• Action: Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.
• Quantity in Commerce: 5 units
• Distribution: CT, HI, LA, MO, PA
• 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 = ESW and Original Applicant = WILSON-COOK MEDICAL, INC.