BEUDAMED
    FDA Enforcement Class I Ongoing

    CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device

    Recall: Z-0964-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-0964-2023
    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 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device

    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 21-7308-24, UDI/DI 30610586032374, Lot Numbers: 4053922 through 4334076; b) REF 21-7309-24, UDI/DI 30610586032381, Lot Numbers: 4062405 through 4334085; c) REF 21-7310-24, UDI/DI 30610586032398, Lot Numbers: 4062404 through 4330874 d) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; e) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870.

    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

    726,878 units