BEUDAMED
    FDA Enforcement Class II Terminated

    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

    Recall: Z-0059-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0059-2015
    Event ID
    69337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    STERILMED, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    September 24, 2014
    Classification Date
    October 9, 2014
    Termination Date
    August 11, 2015
    Address
    11400 73rd Ave N, Maple Grove, MN, 55369-5561, United States

    Description

    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

    Reason

    Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne

    Code Info

    Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577

    Distribution

    US Distribution including the states of WA and CA.

    Quantity

    22