BEUDAMED
    FDA Recall Terminated

    Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.

    Recall: Z-2761-2015 · Initiated August 3, 2015

    Recall

    Recall Number
    Z-2761-2015
    Event Number
    72122
    Firm
    Medivators, Inc.
    FEI Number
    2150060
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 3, 2015
    Posted
    September 11, 2015
    Terminated
    November 4, 2015
    Address
    14605 28th Ave N, Plymouth, MN, 55447-4822

    Description

    Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.

    Reason

    Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.

    Action

    Medivators sent an "Urgent Medical Device" recall letter, dated August 4, 2015, via email. The letter described the issue, identified the affected lot, requested the product be quarantined, and to contact Medivators for return instructions and credit or no-charge replacement product. A response form was requested to be returned to Medivators. Customers with questions can contact Medivators Product at 763-553-3348.

    Distribution

    US Distribution to the states of CA and MI.

    Quantity

    840 units