BEUDAMED
    FDA Recall Terminated

    Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.

    Recall: Z-1512-06 · Initiated July 21, 2006

    Recall

    Recall Number
    Z-1512-06
    Event Number
    35939
    Firm
    Boston Scientific
    FEI Number
    3002095335
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2006
    Posted
    September 23, 2006
    Terminated
    February 3, 2007
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.

    Reason

    Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)

    Action

    On July 21, 2006, Boston Scientific initiated a voluntary recall of 45 lots/batches of Cutting Balloon Ultra Monorail Devices due to their determination that the lots do not meet their sterilization requirements. There is a remote possibility of infection in the patient. An infection, if it occurred, could be recognized and treated effectively in these patients. Boston Scientific is not aware of any complaints related to this product issue. Letters dated July 21, 2006, were sent to their customers with instructions to cease further distribution, complete and return a tracking form, and product return instructions.

    Distribution

    Class II Recall - Nationwide distribution ---- including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, and WY.

    Quantity

    1,000