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RenovoRx, Inc. recalls RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascul
Recalled January 6, 2016 · FDA recall Z-0565-2016 · RenovoRx
Hazard
Incorrect version of Instructions for Use were shipped to two US customers. · FDA Class II
Units
11 units
Sold at
US Distribution to the states of : CA and FL.
Description
Incorrect version of Instructions for Use were shipped to two US customers.
Product
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.
Manufacturer(s)
RenovoRx, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →