BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

    Recall: Z-2019-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2019-2014
    Event ID
    68244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 17, 2014
    Classification Date
    July 8, 2014
    Termination Date
    September 22, 2014
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States

    Description

    Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

    Reason

    An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.

    Code Info

    Catalog Number 801764

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.

    Quantity

    1713 units