BEUDAMED
    FDA Recall Terminated

    Michels Transport Medium, 20ML Prefilled Cont

    Recall: Z-0656-2022 · Initiated December 1, 2021

    Recall

    Recall Number
    Z-0656-2022
    Event Number
    89164
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    NNI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 1, 2021
    Terminated
    February 13, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Michels Transport Medium, 20ML Prefilled Cont

    Reason

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

    Action

    Medline notified customer through first class mail on about 12/01/2021, via letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock and quarantine affected devices, return the completed provided response form indicating affected product on hand and destroyed, and to notify customers if affected product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.

    Distribution

    US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.

    Quantity

    2,816 units (22 cases, 128 per case)