BEUDAMED
    FDA Recall Terminated

    Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.

    Recall: Z-1197-2010 · Initiated February 10, 2010

    Recall

    Recall Number
    Z-1197-2010
    Event Number
    54773
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 10, 2010
    Posted
    March 23, 2010
    Terminated
    April 9, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.

    Reason

    Molding defect in the valve body causes leaking.

    Action

    Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242.

    Distribution

    Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD.

    Quantity

    3230 cases; 32300 units (10 units/case)