BEUDAMED
    FDA Enforcement Class III Terminated

    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

    Recall: Z-1409-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1409-2021
    Event ID
    87302
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OriGen Biomedical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 21, 2021
    Initiation Date
    January 28, 2021
    Classification Date
    April 10, 2021
    Termination Date
    April 19, 2023
    Address
    7000 Burleson Rd Bldg D, N/A, Austin, TX, 78744-3202, United States

    Description

    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

    Reason

    It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

    Code Info

    All Lots

    Distribution

    US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None

    Quantity

    1201 units