BEUDAMED
    FDA Recall Open, Classified

    Lab Kit, SKU DYLAB1018; Component No. 503581

    Recall: Z-0355-2025 · Initiated October 23, 2024

    Recall

    Recall Number
    Z-0355-2025
    Event Number
    95628
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2024
    Posted
    November 12, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Lab Kit, SKU DYLAB1018; Component No. 503581

    Reason

    Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

    Action

    On October 23, 2024, the firm notified customers via Medical Device Recall letters sent through First Class Mail and Email. Customers were informed that the product is actually non-sterile and provided with the full list of impacted convenience kits. Once customers submit the recall response form, they will receive an over-label to place on affected kits, which instruct the user to remove the recalled component. Customers who would like a replacement specimen container may contact their sales representative. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

    Quantity

    626,305 Total Kits (US only)