BEUDAMED
    FDA Enforcement Class I Ongoing

    CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

    Recall: Z-0962-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-0962-2023
    Event ID
    91392
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    December 9, 2022
    Classification Date
    January 30, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

    Reason

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Code Info

    a) REF 21-7346-24: UDI/DI 35019517161957; Lot Numbers: 3776356 through 4320785; b) REF 21-7363-24: UDI/DI 3501951716196; Lot Numbers: 3773412 through 4334343;

    Distribution

    Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN

    Quantity

    1616714 units