Recall Z-0434-2013 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Sentec AG
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.
| Date | Nov 22, 2012 (initiated Nov 5, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 265 boxes (5 per box) |
| Distribution | Distributed only in MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG, Dec 3, 2010 |