Class 2 Device Recall CooperSurgical

• Date Initiated by Firm: October 27, 2014
• Date Posted: December 02, 2014
• Recall Status: Terminated on May 29, 2015
• Recall Number: Z-0484-2015
• Recall Event ID: 69636
• 510(K)Number: K905747
• Product Classification: Electrocautery, gynecologic (and accessories) - Product Code HGI
• Product: CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
• Code Information: Lot 159621 Exp Date: 2017-05
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 75 Vista Pl; Trumbull CT 06611-3934
• For Additional Information Contact: 203-601-5200
• Manufacturer Reason for Recall: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
• FDA Determined Cause: Packaging process control
• Action: CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200.
• Quantity in Commerce: 595 units
• Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
• 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 = HGI