SenTec recalls standard starter sets for potential low electrolyte during membrane changes. This may affect CO2 and oxygen monitoring in medical devices. Affected lots listed in the 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 its Standard Starter Set medical monitoring devices due to a risk of low or reduced electrolyte levels during membrane changes. This could impact the accuracy of oxygen and carbon dioxide monitoring in patients, especially neonates where oxygen monitoring is contraindicated.
The device may apply insufficient electrolyte during membrane changes, which could lead to inaccurate oxygen and carbon dioxide readings. This is particularly concerning for neonates where oxygen monitoring is not safe during gas anesthesia.
Patients using SenTec Standard Starter Sets for continuous monitoring of oxygen, carbon dioxide, and pulse rate. Neonatal patients are at higher risk as oxygen monitoring is contraindicated in this group.
Check the lot numbers listed: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, 190282 for the full set, and 180972, 190078 for the set without service gas.
Identify the lot numbers from the list provided in the recall notice to determine if your device is affected.
The recall is due to an increased chance (about 5%) of low or reduced electrolyte application during membrane changes, which could affect monitoring accuracy.
Yes, oxygen monitoring is contraindicated for neonates under gas anesthesia, so this recall is particularly important for this group.
Check the lot numbers against the list provided in the recall notice to see if your device is affected.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2153-2019 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-2153-2019 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.
