BEUDAMED
    FDA Recall Terminated

    Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.

    Recall: Z-1559-2009 · Initiated May 13, 2009

    Recall

    Recall Number
    Z-1559-2009
    Event Number
    52041
    Firm
    Dixtal Medical, Inc.
    FEI Number
    3006891479
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 13, 2009
    Posted
    June 28, 2009
    Terminated
    March 23, 2012
    Address
    101 N Plains Industrial Rd, Bldg 2, Wallingford, CT, 06492-2360

    Description

    Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.

    Reason

    Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.

    Action

    Urgent Product Recall Notification was issued to affected accounts by email/facsmile on May 8, 2009 requesting to cease distribution, quarantine and return recalled product. Contact Dixtal Medical with questions; to inquire about your on-hand inventory; or to arrange to receive replacement product at Customer Service: [email protected], Phone Number 1-203-269-1112, Fax Number 1-203-269-1760.

    Distribution

    Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.

    Quantity

    27 Boxes (Packaged 25 sensors/box)