BEUDAMED
    FDA Recall Completed

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

    Recall: Z-0478-2023 · Initiated September 3, 2020

    Recall

    Recall Number
    Z-0478-2023
    Event Number
    91092
    Firm
    Allison Medical, Inc.
    FEI Number
    1000138447
    Product Code
    FMF
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 3, 2020
    Posted
    December 13, 2022
    Address
    8091 Shaffer Pkwy, Littleton, CO, 80127-3716

    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.

    Action

    On 9/3/20, and later on 3/2/21, recall notices were emailed to customers who were informed to stop using and destroy or return affected devices to the recalling firm. Customers with additional questions could contact the recalling firm at 801-510-8733.

    Distribution

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

    Quantity

    2,004 Boxes