Device Recall PRECISE RX

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands.
  • Description du dispositif
    This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
  • Société-mère du fabricant (2017)
  • Source
    USFDA