Device Recall ACIST Automated Manifold Kit

  • Model / Serial
    Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, ID, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE,NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT VA, WA, and WI.The countries of CANADA and HONG KONG
  • Product Description
    ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. || The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use.
  • Manufacturer
  • 1 Event

Manufacturer

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