BEUDAMED
    FDA Recall Terminated

    Control, Calibrator Verified, Triage BNP, Model ALR88755

    Recall: Z-3054-2020 · Initiated July 28, 2020

    Recall

    Recall Number
    Z-3054-2020
    Event Number
    86258
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 28, 2020
    Terminated
    February 13, 2023
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Control, Calibrator Verified, Triage BNP, Model ALR88755

    Reason

    Product was shipped with refrigeration (ice) instead of frozen (dry ice).

    Action

    Medline Industries sent formal letters with response forms to affected consignees via 1st class mail on August 3, 2020. Customers were asked to initiate sub-recalls where appropriate. Consignees were provided with a destruction form to return via fax or email. Each destruction form received with be recorded and Medline Industries, Inc. will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. Consignees are asked to confirm the destruction of any affected product on hand.

    Distribution

    Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX

    Quantity

    118 units