Medical device recalls Moderate risk

Us Endovascular recalls USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.

Recall date
February 11, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1362-2016
FDA classification
Class II
Brand / firm
Us Endovascular
Sold / distributed
US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.

Why it was recalled

Product may kink during use rendering the product unusable.

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

What was recalled

USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.

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