BEUDAMED
    FDA Recall 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 · Initiated November 5, 2012

    Recall

    Recall Number
    Z-0434-2013
    Event Number
    63631
    Firm
    Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland
    FEI Number
    3004149774
    Product Code
    LKD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 5, 2012
    Posted
    November 22, 2012
    Terminated
    December 18, 2012

    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.

    Action

    SenTec notified the one US distributor via e-mail on November 5, 2012. The distributor was advised to stop distribution of affected lot numbers. The communication to the distributor described the issue, identified affected product, and stated that SenTec will replace current stock at the end-customer level. The end user can discard the affected products. The distributor is asked to respond back with an e-mail to SenTec that they took appropriate action.

    Distribution

    Distributed only in MO.

    Quantity

    265 boxes (5 per box)