BEUDAMED
    FDA Enforcement Class II Terminated

    Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.

    Recall: Z-2404-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2404-2016
    Event ID
    74664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    May 11, 2016
    Classification Date
    August 11, 2016
    Termination Date
    June 3, 2019
    Address
    1 Medline Pl, Mundelein, IL, 60060-4485, United States

    Description

    Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.

    Reason

    There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.

    Code Info

    Lot Numbers 122211502  122212515

    Distribution

    Continental U.S.

    Quantity

    903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)