BEUDAMED
    FDA Recall Terminated

    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

    Recall: Z-2360-2019 · Initiated May 23, 2019

    Recall

    Recall Number
    Z-2360-2019
    Event Number
    83017
    Firm
    Leventon S. A. U. Calle Newton 18 24 Sant Esteve Sesrovires Barcelona Spain
    FEI Number
    3002807471
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    May 23, 2019
    Terminated
    June 8, 2020

    Description

    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

    Reason

    The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

    Action

    The Firm, LEVENTON, S.A.U., notified customers of recall on June 4, 2019. Distributors were asked to inform customers of the recall. Customers were instructed to return all unused product to the distributor. Distributors were told to destroy all returned product and any remaining product in inventory. Distributors were also provided with recall response forms to complete and return to the recalling firm. If you have questions or concerns, please contact: Quality Director LEVENTON S.A.U. Phone: + 34 93 8176316, Fax: +34 93 8176301 email : [email protected]

    Distribution

    US Distribution to states in: AZ, CA, MA, MI, PR, and FL.

    Quantity

    1700