Class 2 Device Recall TAMPA CATHETER 5 French 33 cm.

• Date Initiated by Firm: May 13, 2014
• Date Posted: June 11, 2014
• Recall Status: Terminated on May 28, 2015
• Recall Number: Z-1782-2014
• Recall Event ID: 68317
• 510(K)Number: K970492
• Product Classification: Cannula, manipulator/injector, uterine - Product Code LKF
• Product: Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
• Code Information: Lot 141525
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 75 Vista Pl; Trumbull CT 06611-3934
• For Additional Information Contact: 203-601-5200
• Manufacturer Reason for Recall: Sterility of the device may be compromised due to unsealed pouch
• FDA Determined Cause: Process control
• Action: Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.
• Quantity in Commerce: 1180 units
• Distribution: Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
• 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 = LKF