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
  • 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
  • 1 Event

Manufacturer

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