BEUDAMED
    FDA Enforcement Class I Ongoing

    Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

    Recall: Z-2286-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2286-2021
    Event ID
    88421
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    August 4, 2021
    Classification Date
    August 21, 2021
    Address
    777 West St, N/A, Mansfield, MA, 02048-1122, United States

    Description

    Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

    Reason

    Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

    Code Info

    20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514

    Distribution

    US Nationwide Distribution:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.

    Quantity

    267,217,860 eaches in total