Events

Recall of Device Recall RenovoCath R120 Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RenovoRx, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72810
  • Event Risk Class
    Class 2
  • Event Number
    Z-0565-2016
  • Event Initiated Date
    2015-11-25
  • Event Date Posted
    2015-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142274
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, intravascular occluding, temporary - Product Code MJN
  • Reason
    Incorrect version of instructions for use were shipped to two us customers.
  • 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.

Device

Device Recall RenovoCath R120 Catheter
  • Model / Serial
    Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA and FL.
  • Product Description
    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
    RenovoRx, Inc.

Manufacturer

RenovoRx, Inc.
  • Manufacturer Address
    RenovoRx, Inc., 4546 El Camino Real Ste 282, Los Altos CA 94022-1068
  • Manufacturer Parent Company (2017)
    RenovoRx, Inc.
  • Source
    USFDA