SenTec recalls neonatal starter sets with potential risk of low electrolyte application during membrane changes. Affected lots include 181089, 190051, 190242, and 181068. 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 neonatal starter sets that may apply insufficient electrolytes during membrane changes, which could affect monitoring accuracy. This risk is low but requires attention for accurate patient monitoring.
The device may not apply enough electrolytes during membrane changes, potentially leading to inaccurate carbon dioxide and oxygen readings. This could affect treatment decisions for neonatal patients.
Neonatal caregivers using the SenTec Neonatal Starter Set for monitoring patients under 1 year old. The risk is highest for infants in critical care settings.
Check the lot numbers: 181089, 190051, 190242 for sets with service gas, and 181068, 190242 for sets without service gas. These sets are used for neonatal monitoring.
Identify affected lots: 181089, 190051, 190242 (with service gas) and 181068, 190242 (without service gas).
There is a 5% chance of applying insufficient electrolytes during membrane changes, which could lead to inaccurate carbon dioxide and oxygen readings.
Affected lots include 181089, 190051, 190242 (with service gas) and 181068, 190242 (without service gas).
The official notice does not specify a remedy.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2154-2019 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-2154-2019 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.
