The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
This recall has been terminated (originally issued October 15, 2015).
- Company
- Clinical Innovations, Llc
- Recall Initiated
- January 5, 2015
- Posted
- October 15, 2015
- Terminated
- April 21, 2016
- Recall Number
- Z-0123-2016
- Quantity
- 827 units
- Firm Location
- Murray, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
Lot / Code Info
Manufacturing lot 1214-F-403 and 1214-V-424
Root Cause
Other
Action Taken
Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.
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