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U.S. Department of Health and Human Services

Class 2 Device Recall The EBB Complete Tamponade System

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  Class 2 Device Recall The EBB Complete Tamponade System see related information
Date Initiated by Firm January 05, 2015
Date Posted October 15, 2015
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = CLINICAL INNOVATIONS, LLC
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