Device Recall Cordis Precise Nitinol Stent

  • Modèle / numéro de série
    All lot numbers of the indicated Product/Catalog numbers.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Product was distributed to 620 hospital accounts nationwide. The firm did not provide information on international accounts. This info was requested from firm and RES will be updated when available.
  • Description du dispositif
    Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014
  • Source
    USFDA