Device Recall AT P54 AngioTouch Kit

  • Modelo / Serial
    0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Acist Medical Systems, 7905 Fuller Road, Eden Prairie MN 55344
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA