BEUDAMED
    FDA Recall Terminated

    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.

    Recall: Z-0431-2013 · Initiated July 26, 2012

    Recall

    Recall Number
    Z-0431-2013
    Event Number
    62834
    Firm
    Stryker Orthobiologics, Inc.
    FEI Number
    1000307073
    Product Code
    LMF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 26, 2012
    Posted
    November 22, 2012
    Terminated
    October 29, 2014
    Address
    45 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.

    Reason

    When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T

    Action

    Stryker sent a "MEDICAL DEVICE FIELD CORRECTION" dated July 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included a Business Reply Form for customers to complete and return via fax to 1-484-323-8803. Contact the firm at 1-888-774-8870 for questions regarding this notice.

    Distribution

    Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV

    Quantity

    3,268