BEUDAMED
    FDA Enforcement Class II Ongoing

    Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

    Recall: Z-2334-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2334-2024
    Event ID
    94794
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MICROspecialties, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 17, 2024
    Initiation Date
    June 5, 2024
    Classification Date
    July 11, 2024
    Address
    430 Smith St, N/A, Middletown, CT, 06457-1531, United States

    Description

    Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

    Reason

    Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

    Code Info

    UDI: 10841305101071 LOT: P63044983R

    Distribution

    MO

    Quantity

    96 units