Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0433-2013 |
| Classification | Class II |
| Code Info | Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D |
| Product Distributed Qty | 195 boxes (9 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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