BEUDAMED
    FDA Recall Terminated

    Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.

    Recall: Z-0842-04 · Initiated March 18, 2004

    Recall

    Recall Number
    Z-0842-04
    Event Number
    28669
    Firm
    Boston Scientific Corp
    FEI Number
    3017892510
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 18, 2004
    Posted
    July 20, 2004
    Terminated
    October 25, 2005
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.

    Reason

    Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.

    Action

    Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product.

    Distribution

    Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI.

    Quantity

    43 units