BEUDAMED
    FDA Enforcement Class II Terminated

    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

    Recall: Z-0932-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0932-2022
    Event ID
    89857
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    March 8, 2022
    Classification Date
    April 14, 2022
    Termination Date
    March 20, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

    Reason

    Product was improperly store which may cause a delay in results.

    Code Info

    Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713 UDI: 00657498000519

    Distribution

    US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA

    Quantity

    45 ea