Device Recall AT P54 AngioTouch Kit

  • Modèle / numéro de série
    0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states AR, AZ, DC, FL, GA, MS, NC, NE, NH, NY, OH, OK, PA, TX, TN,VA, AL, CA, IL, KS, KY, LA, MD, MN, MO, SD, CO, IA, IN, MI, NV, PR, SC, MI, OR, WV, CT, ND, DC, WA, ME, and NJ, and countries of Canada, Brazil, Japan, China, Korea, Thailand, Hong Kong, and Australia.
  • Description du dispositif
    ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. || Catalogue No: 800608-013 || Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Acist Medical Systems, 7905 Fuller Road, Eden Prairie MN 55344
  • Société-mère du fabricant (2017)
  • Source
    USFDA