Class 2 Device Recall CooperSurgical H/S Catheter

• Date Initiated by Firm: July 03, 2014
• Date Posted: September 05, 2014
• Recall Status: Terminated on May 28, 2015
• Recall Number: Z-2570-2014
• Recall Event ID: 68754
• 510(K)Number: K020951
• Product Classification: Cannula, manipulator/injector, uterine - Product Code LKF
• Product: CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
• Code Information: Lot 153914
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 75 Vista Pl; Trumbull CT 06611-3934
• For Additional Information Contact: 203-601-9818
• Manufacturer Reason for Recall: Unsealed pouches.
• FDA Determined Cause: Packaging process control
• Action: Customer notification letter was sent on July 1, 2014 via UPS with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers may have on hand. For questions contact James Keller, Vice President, Regulatory Affairs/Quality Assurance at 203-601-5200.
• Quantity in Commerce: 1,400 units
• Distribution: Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and 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.

• 510(K) Database: 510(K)s with Product Code = LKF