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.
Hazard
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.
What You Should Do
Remedy
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.
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Products
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 r
- Brand
- SenTec AG Ringstrasse 39 Therwil Switzerland
- UPC
- Lots: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264
Units Affected
198 pcs.