SenTec recalls membrane changer inserts for potential electrolyte imbalance during carbon dioxide monitoring. Affected lots include 180759 to 190277. No remedy specified in recall 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 membrane changer inserts that may cause electrolyte issues during carbon dioxide monitoring. This could affect patients using the device for oxygen and pulse rate tracking. The risk is low but requires attention for accurate monitoring.
The inserts may not apply enough electrolyte to the sensor during membrane changes, which could lead to inaccurate readings. This might cause incorrect oxygen or carbon dioxide levels to be reported, potentially affecting patient care decisions.
Adults and pediatric patients using SenTec membrane changer inserts for continuous monitoring of oxygen levels and pulse rate. Neonatal patients using the device for carbon dioxide monitoring only are also affected.
Check the lot numbers listed: 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.
Look for the lot numbers listed in the recall notice to determine if your insert is affected.
There is a 5% chance of not applying enough electrolyte to the sensor during membrane changes, which could lead to inaccurate oxygen or carbon dioxide readings.
Patients using the inserts for continuous monitoring of oxygen levels and pulse rate, including neonatal patients for carbon dioxide monitoring only.
The recall notice does not specify a remedy; affected customers should check the lot numbers and contact SenTec if needed.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2156-2019 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-2156-2019 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.
