Devices

Device Recall AT P54 AngioTouch Kit

  • Model / Serial
    0368H, 0368J, 0378L, 0388F, 0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T, 0848K, 0848L, 0878M, and 0918N.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Acist Medical Systems
  • 1 Event

Manufacturer

Acist Medical Systems
  • Manufacturer Address
    Acist Medical Systems, 7905 Fuller Road, Eden Prairie MN 55344
  • Manufacturer Parent Company (2017)
    Bracco Spa
  • Source
    USFDA