BEUDAMED
    FDA Enforcement Class II Terminated

    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

    Recall: Z-2149-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2149-2012
    Event ID
    62563
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Apheresis Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    August 15, 2012
    Initiation Date
    July 9, 2012
    Classification Date
    August 6, 2012
    Termination Date
    December 16, 2013
    Address
    612 Florida Ave, Palm Harbor, FL, 34683-5459, United States

    Description

    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

    Reason

    On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.

    Code Info

    D11003544 through D11003552 D11003556 through D11003558

    Distribution

    Natonwide Distribution

    Quantity

    13