BEUDAMED
    FDA Recall 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 · Initiated July 9, 2012

    Recall

    Recall Number
    Z-2149-2012
    Event Number
    62563
    Firm
    Apheresis Technologies, Inc.
    FEI Number
    1000113717
    Product Code
    FIR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 9, 2012
    Posted
    August 6, 2012
    Terminated
    December 16, 2013
    Address
    612 Florida Ave, Palm Harbor, FL, 34683-5459

    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.

    Action

    APHERESIS TECHNOLOGIES, INC. sent a letter dated July 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the device for repair. For questions customers should call 727-787-5616.

    Distribution

    Natonwide Distribution

    Quantity

    13