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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product 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.
Recall Number Z-0434-2013
Classification Class II
Code Info Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
Product Distributed Qty 265 boxes (5 per box)
Reason For Recall 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.

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.
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