RenovoRx, Inc. recalls RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: T…

Recall date

November 25, 2015

Source

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

Recall number

Z-0565-2016

FDA classification

Class II

Brand / firm

RenovoRx, Inc.

Sold / distributed

US Distribution to the states of : CA and FL.

Why it was recalled

Incorrect version of Instructions for Use were shipped to two US customers.

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

What was recalled

RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.