BEUDAMED
    FDA Enforcement Class II Terminated

    3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

    Recall: Z-0318-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0318-2021
    Event ID
    85124
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 11, 2020
    Initiation Date
    June 24, 2019
    Classification Date
    October 30, 2020
    Termination Date
    July 14, 2021
    Address
    7000 Burleson Rd Bldg D, N/A, Austin, TX, 78744-3202, United States

    Description

    3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

    Reason

    The firm has become aware that they have distributed product that was expired.

    Code Info

    Lot # 042417-5045

    Distribution

    US: TX

    Quantity

    6 units