BEUDAMED
    FDA Recall Terminated

    CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.

    Recall: Z-0604-2012 · Initiated December 7, 2011

    Recall

    Recall Number
    Z-0604-2012
    Event Number
    60479
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DRY
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    December 7, 2011
    Posted
    January 11, 2012
    Terminated
    August 30, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed.

    Reason

    Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device.

    Action

    12/7/11 & 12/8/11 All consignees received a "Transition and Notification Guide" dated 12/6/11 and a "URGENT MEDICAL DEVICE REMOVAL" letter dated 12/4/11, which will inform them of the removal of the CD l 101 and provide the user with various options. Terumo will remove CD l 101 units from the US market over the next 18 months.

    Distribution

    Nationwide Distribution - Including the states of: NV, MO, SC, WA, MI, FL, GA, NY, CT, IL, VA, NY, TN, IN, HI, TX, AL, OH, MD, AZ, CA, KS, MD, PA, and NM.

    Quantity

    366