BEUDAMED
    FDA Enforcement Class II Terminated

    Premier Rotaclone, Rx only

    Recall: Z-0552-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0552-2022
    Event ID
    89165
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 9, 2022
    Initiation Date
    December 1, 2021
    Classification Date
    February 2, 2022
    Termination Date
    February 13, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Premier Rotaclone, Rx only

    Reason

    Product stored incorrectly in temperature controlled setting instead of refrigeration.

    Code Info

    Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023

    Distribution

    US Nationwide distribution in the states of California and Massachusetts.

    Quantity

    34 units