BEUDAMED
    FDA Enforcement Class II Terminated

    OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    Recall: Z-0790-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0790-2017
    Event ID
    75785
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oscor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2016
    Initiation Date
    October 5, 2016
    Classification Date
    December 19, 2016
    Termination Date
    July 26, 2019
    Address
    3816 Desoto Blvd, N/A, Palm Harbor, FL, 34683-1618, United States

    Description

    OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    Reason

    Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

    Code Info

    Lot #'s: C1-09714 Exp. February 11, 2018, OR-04657 Exp. April 20, 2018, C1-10900 Exp. July 19, 2018, C1-10899 Exp. July 19, 2018, C1-11048 Exp. August 3, 2018, C1-11729 Exp. October 4, 2018, C1-11729 Exp. October 4, 2018, OR-04729 Exp. October 29, 2018, C1-12233 Exp. December 21, 2018, C1-12234 Exp. December 22, 2018, C1-12234 Exp. December 22, 2018, C1-09062 Exp. June 24, 2017, C1-09062 Exp. June 24, 2017, C1-11047 Exp. August 3, 2018 and C1-12234 Exp. December 22, 2018 2

    Distribution

    Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

    Quantity

    156