BEUDAMED
    FDA Recall Terminated

    SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

    Recall: Z-0035-2007 · Initiated July 28, 2006

    Recall

    Recall Number
    Z-0035-2007
    Event Number
    36005
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2006
    Posted
    October 12, 2006
    Terminated
    October 24, 2006
    Address
    400 Wood Rd, Eastern Maine Medical Center Braintree, MA, 02184-2412

    Description

    SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

    Reason

    Faulty circuit board may short circuit and cause electric shock to operator

    Action

    Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.

    Distribution

    AZ, CT, GA, NE, MS Austria, France, Taiwan

    Quantity

    15 units