BEUDAMED
    FDA Recall Open, Classified

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    Recall: Z-1953-2018 · Initiated February 26, 2018

    Recall

    Recall Number
    Z-1953-2018
    Event Number
    80024
    Firm
    Genesee BioMedical, Inc.
    FEI Number
    1000517719
    Product Code
    DWS
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    February 26, 2018
    Address
    700 W Mississippi Ave, Unit D5, Denver, CO, 80223-4509

    Description

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    Reason

    Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.

    Action

    The customer communication letter, dated February 26, 2018, was mailed or emailed. The letter describes the concern and the user action. A copy of the revised Instructions for Use will be provided with the letter. All consignees in the US and outside of the US who have not been previously contacted will receive notification.

    Distribution

    Worldwide distribution. US nationwide, South Korea, Australia, COSTA RICA, Taiwan, New Zealand, Italy, Canada, Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, United Kingdom

    Quantity

    444 units