FDA recall Z-2152-2019

SenTec AG · Class II · device

Product

SenTec Membrane Changer (reloadable) [9 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 for recall

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.

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, Finland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates and United Kingdom.

Key facts

Status
Terminated
Initiation date
2019-05-02
Report date
2019-08-14
Termination date
2020-12-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Therwil, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2152-2019