Recall Z-0123-2016
Clinical Innovations, LLC · initiated January 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Manufacturing lot 1214-F-403 and 1214-V-424
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 taken
Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.
Details
- Recall number
- Z-0123-2016
- Initiated
- January 5, 2015
- Posted by FDA
- October 15, 2015
- Terminated
- April 21, 2016
- Product code
- OQY – Intrauterine Tamponade Balloon
- Quantity
- 827 units
- Distribution
- Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
- Recalling firm
- Clinical Innovations, LLC, Murray, UT