BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0269-2019 · Initiated March 30, 2015

    Recall

    Recall Number
    Z-0269-2019
    Event Number
    81164
    Firm
    OriGen Biomedical, Inc.
    FEI Number
    1000160256
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 30, 2015
    Posted
    November 7, 2018
    Terminated
    March 1, 2024
    Address
    7000 Burleson Rd, Bldg D, Austin, TX, 78744-3202

    Description

    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.

    Reason

    Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage

    Action

    On April 1, 2015 the firm sent an MEDICAL DEVICE MARKET WITHDRAWAL to customers/distributors via email to inform them the catheters may start to show signs of failure at the junction of the clear extension tube and blue hub connection that can be recognized by air entrainment or blood leakage. If the preliminary failure is identified, the catheter should be replaced immediately. Serious injuries could occur due to the failure mode. The customers are instructed to discontinue use of all products from the affected lot and to return any unused products immediately and to complete and return the acknowledgement and receipt form even if the customer does not currently have products in its inventory. The firm is conducting an investigation to determine root cause of the failure and will notify the customers when the investigation has been completed and when replacement products are available. If customers have any questions regarding the return of product or the status of the investigation, they can contact: OriGen Biomedical Attn: Bernie R Silvers 7000 Burleson Road, Building D Austin, TX 78744 Phone Number +1 512-474-7278

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom

    Quantity

    134