BEUDAMED
    FDA Enforcement Class II Terminated

    Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

    Recall: Z-0404-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0404-2022
    Event ID
    89150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 29, 2021
    Initiation Date
    November 30, 2021
    Classification Date
    December 21, 2021
    Termination Date
    January 6, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

    Reason

    Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

    Code Info

    Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.

    Distribution

    US Nationwide distribution in the states of IL, OH, MS, and PA.

    Quantity

    14 units (individual)