BEUDAMED
    FDA Recall Terminated

    PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    Recall: Z-1654-2012 · Initiated November 29, 2010

    Recall

    Recall Number
    Z-1654-2012
    Event Number
    61621
    Firm
    Apheresis Technologies, Inc.
    FEI Number
    1000113717
    Product Code
    FIR
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    November 29, 2010
    Posted
    May 24, 2012
    Terminated
    May 25, 2012
    Address
    612 Florida Ave, Palm Harbor, FL, 34683-5459

    Description

    PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    Reason

    Apheresis Technologies, Inc., Palm Harbor, FL, initiated a voluntarily withdrawal on November 29, 2010 of their five (5) units of the Plasma Pro Plasma Pump and later classified as a recall (removal) rather than a withdrawal, Model # PP-05, Serial Numbers: E08003041, E08003042, E08003043, E08003044 and E08003045.

    Action

    Apheresis Technologies sent a Letter by FedEx to their two consignees. The letter notified customers of the voluntary recall initiated, affected product and description of the problem. For questions call 727-784-2353 or 1-800-382-5556.

    Distribution

    US Nationwide Distribution including the states of Colorado and Utah.

    Quantity

    5 units