BEUDAMED
    FDA Enforcement Class II Ongoing

    Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.

    Recall: Z-1944-2024 · Reported June 12, 2024

    Enforcement

    Recall Number
    Z-1944-2024
    Event ID
    94479
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BD SWITZERLAND SARL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2024
    Initiation Date
    April 18, 2024
    Classification Date
    May 31, 2024
    Address
    Terre Bonne Park A4, Route De Crassier 17, Eysins, N/A, N/A, Switzerland

    Description

    Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.

    Reason

    Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

    Code Info

    Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.

    Quantity

    11.300 sets