BEUDAMED
    FDA Recall Terminated

    Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F

    Recall: Z-0503-03 · Initiated December 17, 2002

    Recall

    Recall Number
    Z-0503-03
    Event Number
    25342
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 17, 2002
    Posted
    January 30, 2003
    Terminated
    January 28, 2016
    Address
    400 Wood Road, Braintree, MA, 02184

    Description

    Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F

    Reason

    Disposable Set for Autologous Blood recovery may leak saline at the Y-connector

    Action

    Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.

    Distribution

    Nationwide Canada

    Quantity

    12