BEUDAMED
    FDA Enforcement Class II Ongoing

    Various hysterectomy, vaginal packs

    Recall: Z-1702-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1702-2022
    Event ID
    90574
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 14, 2022
    Initiation Date
    June 16, 2022
    Classification Date
    September 8, 2022
    Address
    2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States

    Description

    Various hysterectomy, vaginal packs

    Reason

    Product was exposed to multiple sterilization cycles without validation for multiple exposures.

    Code Info

    Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRGYOSCOPYG, 2104281, 888211, 63995389 2) LSRLMGLAPF, 2105282, 856211, 44252282 3) LSRHPGYND, 2106092, 847211, 14887375 4) LSRHPGYND, 2106092, 847211, 14887374 5) LSRHPGYND, 2106092, 847211, 14887373 6) AMJL22Z, 2106112, 840211, 64176443 7) FDMN88N, 2107013, 821211, 64168939 8) MMJL16C, 2108023, 791211, 44180974 9) UIGY37AA, 2108033, 789211, 64104498 10) FHGG12V, 2109131, 748211, 64223133 11) BHOB33G, 2104191, 894211, 14870011-004 12) AHHY33M, 2105131, 867211, 14874336-004 13) MEHY02M, 2106152, 834211, 15003746-004 14) MEHY02M, 2106152, 834211, 15003740-004 15) MEHY02M, 2106152, 834211, 15003713-004 16) MEHY02M, 2106152, 834211, 15003709-004 17) MEHY02M, 2106152, 834211, 15003704-004 18) MEHY02M, 2106152, 834211, 15001377-004 19) MEHY02M, 2106152, 834211, 15003712-004 20) CXVG89X, 2106171, 833211, 43996010-005 21) SLGG63G, 2106282, 821211, 64071565-006 22) BHVR88A, 2106291, 828211, 64090094-006 23) UMVG16A, 2109031, 756211, 63998597-006 24) BHVP17H, 2106071, 845211, 14901608-004 25) BHVP17H, 2106071, 845211, 14901609-004 26) BHVP17H, 2108051, 785211, 15028595-004 27) BHVP17H, 2109031, 755211, 15023691-004 28) MCGY26E, 2109071, 754211, 44261563-005 29) MPGY64E, 2109081, 754211, 44261561-005

    Distribution

    Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

    Quantity

    29 units