BEUDAMED
    FDA Enforcement Class II Ongoing

    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

    Recall: Z-1057-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1057-2022
    Event ID
    89952
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SIMPLIVIA HEALTHCARE LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 18, 2022
    Initiation Date
    March 8, 2022
    Classification Date
    May 11, 2022
    Address
    NORTH IND. ZONE, (MIGADA PLANT), NORTH IND. ZONE PoBOX 888, Kiryat Shmona, N/A, N/A, Israel

    Description

    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

    Reason

    Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

    Code Info

    UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536

    Distribution

    Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.

    Quantity

    293,520