BEUDAMED
    FDA Recall Terminated

    Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.

    Recall: Z-1663-2008 · Initiated March 11, 2008

    Recall

    Recall Number
    Z-1663-2008
    Event Number
    47343
    Firm
    Ascent Healthcare Solutions, Inc.
    FEI Number
    1000132435
    Product Code
    NLF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 11, 2008
    Posted
    September 19, 2008
    Terminated
    June 29, 2012
    Address
    5307 Great Oak Drive, Lakeland, FL, 33815-3113

    Description

    Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse Oximeter.

    Reason

    Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

    Action

    A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at [email protected].

    Distribution

    Class II Recall - Nationwide Distribution.

    Quantity

    1752 of 1752 (data indicates 1776 dist - some devices were returned and redistributed)