FDAJanuary 5, 2015device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
clinical innovationsclinical
Recall history
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