BEUDAMED
    FDA Recall Terminated

    Venoscope Neonatal Transilluminator, Model NT01

    Recall: Z-0116-2007 · Initiated April 28, 2005

    Recall

    Recall Number
    Z-0116-2007
    Event Number
    36548
    Firm
    Venoscope LLC
    FEI Number
    1000306918
    Product Code
    HJN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2005
    Posted
    October 28, 2006
    Terminated
    February 21, 2007
    Address
    1018 Harding Street, Suite 104, Lafayette, LA, 70503

    Description

    Venoscope Neonatal Transilluminator, Model NT01

    Reason

    Excessive heating due to incorrect wire assembly process.

    Action

    The firm notified its consignees about the problem beginning on 04/28/2006 and requested the consignee (nurses and distributors) open the battery compartment and check for the absence of an identifying mark (there are no exterior lot numbers). The recalling firm requested the return of all lights which had no identifying marks inside the battery compartment.

    Distribution

    Nationwide

    Quantity

    118 distributed