Device Recall Optiflux F250NRe Hemodialyzer

  • Model / Serial
    Lot numbers:  10HU02012, Expiration Date: 06/30/2013; and  10LU02016, Expiration Date: 09/30/2013.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. || Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
  • Source
    USFDA