BEUDAMED
    FDA Enforcement Class II Terminated

    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    Recall: Z-0434-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0434-2013
    Event ID
    63631
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sentec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    November 5, 2012
    Classification Date
    November 22, 2012
    Termination Date
    December 18, 2012
    Address
    Ringstrasse 39, N/A, Therwil, Baselland, N/A, N/A, Switzerland

    Description

    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.

    Reason

    A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.

    Code Info

    Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F

    Distribution

    Distributed only in MO.

    Quantity

    265 boxes (5 per box)