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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012
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Event Detail

Event ID 63631
Product Type Devices
Status Ongoing
Recalling Firm Sentec AG
City Therwil, Baselland
State
Country CH
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-05
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern Distributed only in MO.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor 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. Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D Class II 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. 195 boxes (9 per box) Z-0433-2013
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. Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F Class II 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. 265 boxes (5 per box) Z-0434-2013
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