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

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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