SenTec recalls 9-piece Membrane Changer sets for potential low electrolyte application during sensor changes, affecting continuous CO2 and oxygen monitoring in medical patients. No remedy specified in official notice.
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.
SenTec is recalling 9-piece Membrane Changer sets that may apply insufficient electrolytes during sensor changes. This could affect accurate carbon dioxide and oxygen monitoring in medical patients, though the risk is low (about 5%).
The device may not apply enough electrolytes during membrane changes, which could lead to inaccurate oxygen and CO2 readings. This risk occurs in about 5% of cases during normal use. Inaccurate readings might affect patient monitoring decisions.
Medical patients using continuous non-invasive monitoring for oxygen, CO2, and pulse rate. Neonatal patients are at higher risk as oxygen monitoring is contraindicated under gas anesthesia.
Check for SenTec Membrane Changer sets with lot numbers: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264.
Look for lot numbers listed in the recall: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264.
The device is safe for most patients, but there is a 5% chance of low electrolyte application during membrane changes, which could affect monitoring accuracy.
Neonatal patients are at higher risk because oxygen monitoring is contraindicated under gas anesthesia.
Check the lot numbers listed in the recall. If you have a matching lot, contact SenTec for guidance.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2152-2019 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-2152-2019 from SenTec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
