BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

    Recall: Z-2018-2014 · Initiated June 17, 2014

    Recall

    Recall Number
    Z-2018-2014
    Event Number
    68244
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    June 17, 2014
    Posted
    July 8, 2014
    Terminated
    September 22, 2014
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 100/120V 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.

    Action

    On June 17, 2014, TCVS sent URGENT MEDICAL DEVICE RECALL notification to consignees. Notification included reason for recall, potential hazard, correction, affected population, and customer instructions. Questions concerning the recall are directed to Terumo CVS Customer Service @ 800-521-2818 (M-F, 8am-6pm)

    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