BEUDAMED
    FDA Recall Terminated

    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

    Recall: Z-0022-2014 · Initiated September 11, 2013

    Recall

    Recall Number
    Z-0022-2014
    Event Number
    66268
    Firm
    Harvest Technologies Corporation
    FEI Number
    1000117351
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 11, 2013
    Posted
    October 17, 2013
    Terminated
    February 10, 2014
    Address
    40 Grissom Rd, Ste 100, Plymouth, MA, 02360-7205

    Description

    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

    Reason

    Potential for leur connector to leak or have cracks.

    Action

    Harvest Technologies sent a notification letter dated September 10, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form to confirm the number of kits received, used, and intending to return. They are asked to return the kits with the form. For questions contact Michelle Sullivan at 508-732-7500.

    Distribution

    Worldwide Distribution - USA Nationwide: TX, NJ, MI, AZ, GA, LA, ME, MD, AR, MO, VA, MN, GA, MA, NY, PA, CO, CA and in the countries of Australia, Brazil, China, Singapore, Vietnam, Dominican Republic.

    Quantity

    730 cases (3 kits per case)