BEUDAMED
    FDA Enforcement Class I Terminated

    Presource PBDS, Shoulder Procedure, Kit, Circulator

    Recall: Z-1201-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1201-2013
    Event ID
    64736
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health, Medical Products & Services
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    March 26, 2013
    Classification Date
    May 3, 2013
    Termination Date
    April 12, 2017
    Address
    1430 Waukegan Road, Attn V. Mueller Qa, Park City, IL, 60085, United States

    Description

    Presource PBDS, Shoulder Procedure, Kit, Circulator

    Reason

    Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

    Code Info

    Catalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668

    Distribution

    Distributed in the states of AR, MS, SC, and TN.

    Quantity

    4,571 Kits total