BEUDAMED
    FDA Enforcement Class II Terminated

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    Recall: Z-2062-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2062-2015
    Event ID
    71271
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    July 13, 2015
    Termination Date
    October 19, 2015
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    Reason

    Potential sterility breach in the packaging.

    Code Info

    0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012

    Distribution

    Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.

    Quantity

    5,328 each (444 boxes)