FDA-Device2015-10-21Class II
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Clinical Innovations, LLC
Hazard
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.
Sold states
Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
Affected count
827 units
Manufactured in
747 W 4170 S, N/A, Murray, UT, United States
Products
The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2016Don't want to check this manually?
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