Recall Z-2153-2019 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contra
| Date | May 2, 2019 |
| Status | Terminated |
| Reason | There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. |
| Root cause | Process control |
| Action | On May 2, 2019, the firm sent Guidance for SenTec Distributors to their distributors advising them of the issue, requesting them to check their stock and notify their end users via a voluntarily initiated field correction action associated with Membrane Changers and their Inserts which was enclosed with the "recall" letters. The distributors were to report back to SenTec via email. |
| Quantity | 22 pcs |
| Distribution | Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc., Aug 9, 2004 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG, Dec 3, 2010 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, Dec 17, 2015 |