FDA Device recall Z-2156-2019
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and o…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and o… by Sentec Ag, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2156-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-02 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Sentec Ag |
| Distribution | US |
Product
SenTec Membrane Changer Insert [5 pcs - 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 contraindicated for patients under gas anesthesia.]
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.
Identifiers
| code_info | Lots: 180759, 180766, 180788, 180814, 180830, 180831, 180837, 180839, 180868, 180869, 180870, 180918, 180933, 180938, 1…Lots: 180759, 180766, 180788, 180814, 180830, 180831, 180837, 180839, 180868, 180869, 180870, 180918, 180933, 180938, 180941, 180984, 180996, 181014, 181027, 181035, 181059, 181070, 181083, 181092, 181100, 181142, 190016, 190028, 190032, 190073, 190088, 190100, 190125, 190143, 190163, 190170, 190215, 190236, 190240, 190262, and 190277 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2156-2019%22
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