BEUDAMED
    FDA Enforcement Class II Ongoing

    Various Pacemaker Packs, Cardio Thoracic Packs

    Recall: Z-1691-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1691-2022
    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 Pacemaker Packs, Cardio Thoracic 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) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASING, 2107102, 817211, 64116041 3) LSRSMVEINB, 2107221, 810211, 64119459 4) LSRCFHENDAE, 2107171, 807211, 64116602 5) UICT16E, 2108183, 771211, 15066268 6) BHOH94I, 2104141, 897211, 63987116-006 7) BHOH95, 2104301, 902211, 44123693-005 8) ANCV60AI, 2105201, 860211, 63956881-006 9) UDIP97AD, 2105201, 860211, 14858003-004 10) CEFS17I, 2105262, 855211, 44132805-005 11) FHPM10P, 2106092, 840211, 44129541-005 12) SLCV01E, 2107081, 812211, 64110741-006 13) SLEP03F, 2108271, 761211, 44314505-005 14) SLEP03F, 2108271, 761211, 44314504-005 15) CXCV91X, 2108311, 757211, 44315778-005 16) MECV98V, 2108312, 757211, 44313827-005 17) SAPA90X, 2108311, 758211, 64204754-006 18) SLCV01E, 2109161, 742211, 64208360-006 19) MEEP10F, 2109202, 740211, 64220361-006 20) UMOH42C, 2105072, 876211, 64061399-006 21) BHON40H, 2108122, 778211, 64095875-006 22) BHPM60F, 2108122, 779211, 44216056-005 23) BHCA27C, 2109072, 754211, 63997844-006 24) BHPM60F, 2109292, 728211, 44353475-005

    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

    24 units