BEUDAMED
    FDA Enforcement Class II Completed

    CarePoint 60 mL Syringe Without Needle, REF: 04-7560

    Recall: Z-0478-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0478-2023
    Event ID
    91092
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Allison Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    September 3, 2020
    Classification Date
    December 13, 2022
    Address
    8091 Shaffer Pkwy, N/A, Littleton, CO, 80127-3716, United States

    Description

    CarePoint 60 mL Syringe Without Needle, REF: 04-7560

    Reason

    Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

    Code Info

    UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522

    Distribution

    US: IA, LA, MS, FL, PR; OUS: BARBADOS

    Quantity

    2,004 Boxes