Clinical Innovations, LLC recalls The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or re…

Recall date

January 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0123-2016

FDA classification

Class II

Brand / firm

Clinical Innovations, LLC

Sold / distributed

Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.