Device Recall IntelliFill i.v. Pharmacy Compounding Device (PCD)

  • Modèle / numéro de série
    Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.
  • Description du dispositif
    IntelliFill i.v. Pharmacy Compounding Device (PCD). || Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
  • Source
    USFDA