BEUDAMED
    FDA Recall Terminated

    Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040

    Recall: Z-0697-2007 · Initiated February 7, 2007

    Recall

    Recall Number
    Z-0697-2007
    Event Number
    37403
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2007
    Posted
    March 31, 2007
    Terminated
    November 15, 2007
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040

    Reason

    SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

    Action

    Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

    Distribution

    Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .

    Quantity

    12 units