BEUDAMED
    FDA Enforcement Class II 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 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0431-2013
    Event ID
    62834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Orthobiologics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    July 26, 2012
    Classification Date
    November 22, 2012
    Termination Date
    October 29, 2014
    Address
    45 Great Valley Pkwy, N/A, Malvern, PA, 19355-1302, United States

    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

    Code Info

    Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.

    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