BEUDAMED
    FDA Recall Terminated

    Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    Recall: Z-1897-2009 · Initiated April 1, 2009

    Recall

    Recall Number
    Z-1897-2009
    Event Number
    52640
    Firm
    Apheresis Technologies, Inc.
    FEI Number
    1000113717
    Product Code
    FIR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 1, 2009
    Posted
    August 27, 2009
    Terminated
    July 6, 2010
    Address
    612 Florida Ave, Palm Harbor, FL, 34683-5459

    Description

    Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.

    Reason

    Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.

    Action

    PlasmaPro Plasma Pump Operators Manual was modified and distributed to firms consignees. Firms received written notification of re-issuance of Operator's Manual.

    Distribution

    Nationwide Distribution -- Florida, Colorado and Utah.

    Quantity

    7 Owner's Manuals