Class 2 Device Recall The EBB Complete Tamponade System

• Date Initiated by Firm: January 05, 2015
• Date Posted: October 15, 2015
• Recall Status: Terminated on April 21, 2016
• Recall Number: Z-0123-2016
• Recall Event ID: 72018
• 510(K)Number: K150573
• Product Classification: Intrauterine tamponade balloon - Product Code OQY
• Product: The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
• Code Information: Manufacturing lot 1214-F-403 and 1214-V-424
• FEI Number: 1000220650
• Recalling Firm/ Manufacturer: Clinical Innovations, LLC; 747 W 4170 S; Murray UT 84123-1364
• For Additional Information Contact: Thomas D. Haueter; 801-268-8200
• Manufacturer Reason for Recall: Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
• FDA Determined Cause: Other
• Action: Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.
• Quantity in Commerce: 827 units
• Distribution: Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
• 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 = OQY