Device Recall RenovoCath R120 Catheter

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : CA and FL.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    RenovoRx, Inc., 4546 El Camino Real Ste 282, Los Altos CA 94022-1068
  • Société-mère du fabricant (2017)
  • Source
    USFDA