BEUDAMED
    FDA Recall Open, Classified

    ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

    Recall: Z-0018-2025 · Initiated June 26, 2024

    Recall

    Recall Number
    Z-0018-2025
    Event Number
    95305
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 26, 2024
    Posted
    October 18, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

    Reason

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    Action

    Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: [email protected] 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 [email protected]

    Distribution

    Worldwide distribution.

    Quantity

    120960 units