BEUDAMED
    FDA Recall Terminated

    Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP

    Recall: Z-0823-06 · Initiated December 21, 2005

    Recall

    Recall Number
    Z-0823-06
    Event Number
    34372
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 21, 2005
    Posted
    April 29, 2006
    Terminated
    March 12, 2008
    Address
    400 Wood Rd, Braintree, MA, 02184-2412

    Description

    Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP

    Reason

    Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard

    Action

    Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .

    Distribution

    Nationwide

    Quantity

    151 units