BEUDAMED
    FDA Enforcement Class II Terminated

    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage

    Recall: Z-1418-2014 · Reported April 16, 2014

    Enforcement

    Recall Number
    Z-1418-2014
    Event ID
    67757
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aspen Surgical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 16, 2014
    Initiation Date
    March 20, 2014
    Classification Date
    April 7, 2014
    Termination Date
    November 25, 2014
    Address
    6945 Southbelt Dr Se, N/A, Caledonia, MI, 49316-7664, United States

    Description

    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage

    Reason

    The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

    Code Info

    Product Number 310007

    Distribution

    Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.

    Quantity

    N/A