BEUDAMED
    FDA Enforcement Class II Terminated

    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

    Recall: Z-0119-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0119-2019
    Event ID
    81113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cypress Medical Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 24, 2018
    Initiation Date
    September 4, 2018
    Classification Date
    October 16, 2018
    Termination Date
    May 28, 2024
    Address
    9954 Mayland Dr, N/A, Richmond, VA, 23233-1464, United States

    Description

    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

    Reason

    Small hole at the end of the syringe is impeding suction of liquid.

    Code Info

    Lot Code: KSH0603

    Distribution

    US Nationwide Distribution

    Quantity

    400 cases