Device Recall Optiflux 180NR

  • Model / Serial
    Lot # 7LU416
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.
  • Product Description
    Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
  • Manufacturer
  • 1 Event

Manufacturer

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