BEUDAMED
    FDA Enforcement Class II Completed

    InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC

    Recall: Z-0266-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0266-2023
    Event ID
    91083
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Allison Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2022
    Initiation Date
    January 19, 2018
    Classification Date
    November 18, 2022
    Address
    8091 Shaffer Pkwy, N/A, Littleton, CO, 80127-3716, United States

    Description

    InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC

    Reason

    Insulin syringe retail packages incorrectly labeled as "Short Needle".

    Code Info

    UDI/Lot/Expiration: 00041220791484/ 170407/ 2022-03-31

    Distribution

    Texas

    Quantity

    1,500 Boxes (150,000 syringes)