Class 2 Device Recall CMax

• Date Initiated by Firm: October 12, 2016
• Create Date: November 16, 2016
• Recall Status: Terminated on October 05, 2021
• Recall Number: Z-0585-2017
• Recall Event ID: 75428
• Product Classification: Electrode, electrosurgical, active, urological - Product Code FAS
• Product: C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.
• Code Information: Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854
• FEI Number: 1018233
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: Jeff DeSanty; 401-825-8690
• Manufacturer Reason for Recall: Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter on 10/12/2016.
• Quantity in Commerce: 70 units
• Distribution: FL, GA, LA, OH, VA and WA.
• 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.