BEUDAMED
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    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

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code KJA·January 28, 2021

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017

    ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017

    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·March 30, 2015

    Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·March 30, 2015

    Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 2, 2017

    Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017

    Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744

    FDA Recall
    Terminated ·Origen Biomedical, Inc·Product code DQO·December 16, 2002

    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

    Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·August 21, 2018

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

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code KFM·June 24, 2019

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code DWF·January 17, 2017

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

    FDA Enforcement
    Class I ·Terminated·OriGen Biomedical, Inc.·June 12, 2019