Class 2 Device Recall Endoscopic Introducer/Extractor

• Date Initiated by Firm: April 25, 2017
• Create Date: June 14, 2017
• Recall Status: Terminated on March 26, 2019
• Recall Number: Z-2538-2017
• Recall Event ID: 77217
• Product Classification: Guide, surgical, instrument - Product Code FZX
• Product: Endoscopic Introducer/Extractor
• Code Information: All lots Catalog numbers: J-EIE-051500
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Departme; 800-457-4500
• Manufacturer Reason for Recall: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
• FDA Determined Cause: Labeling design
• Action: On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
• Quantity in Commerce: 46
• Distribution: The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
• 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.