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.
FDA Recall Z-0565-2016 · Posted 2015-12-31
Recalling FirmRenovoRx, Inc.
Recall StatusTerminated
Product CodeMJN
Date Initiated2015-11-25
Date Terminated2016-02-29
Product Quantity11 units
Reason for Recall
Incorrect version of Instructions for Use were shipped to two US customers.
Firm Action
RenovoRx notified customers by phone and by mail of this issue. This notification requests that the customers remove the affected product from their inventory and remove and replace the incorrect Instructions for Use with the correct Instructions for Use provided by RenovoRx.
The customers are requested to return the incorrect Instruction for Use to RenovoRx for disposition and are requested to complete a Recall Confirmation Form enclosed to document the completion of the requested Correction.
For further questions, please call (650) 284-4433.
Root Cause
Labeling Change Control
Distribution Pattern
US Distribution to the states of : CA and FL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.