SenTec recalls Membrane Changers (MC, MC-R, MC-I) due to potential manufacturing defect that could impact measurement accuracy. Affected units include specific model numbers and serials.
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
SenTec is recalling its Membrane Changer Single-Use (REF MC), Reloadable (REF MC-R), and Insert (REF MC-I) components because a small piece of material may have been left inside during manufacturing. This could cause measurement errors in the Sentec Digital Monitoring System (SDMS).
During manufacturing, a small piece of material may have been left inside the device. This can interfere with the device's measurement performance, potentially causing inaccurate readings. The issue does not involve physical harm but affects the device's functionality.
Users of the Sentec Digital Monitoring System (SDMS) who own the recalled Membrane Changers (REF MC, MC-R, or MC-I) are affected. Those using the SDMS for precise measurements may be at slightly higher risk.
Check if your Membrane Changer has a model number starting with REF MC, MC-R, or MC-I. The specific model numbers and UDI-DI numbers are listed in the recall notice. All recalled items are components of the Sentec Digital Monitoring System (SDMS).
Identify if your Membrane Changer has a model number starting with REF MC, MC-R, or MC-I.
Reach out to SenTec AG to confirm if your device is affected and get guidance on next steps.
The recall is due to a potential manufacturing defect where a small piece of material may have been left inside the device during production, which could affect measurement accuracy.
Affected model numbers include REF MC (230441, 230224, etc.), REF MC-R (230461, 230329, etc.), and REF MC-I (230372, 230339, etc.) as listed in the recall notice.
No, the recall does not require immediate discontinuation. The hazard is low-risk and only affects measurement accuracy, not physical safety.
We’ve drafted a message you can send SenTec to request your refund or repair — edit it as you like.
Subject: Recall Z-2592-2023 — SenTec SenTec Hello, I own a SenTec that is covered by recall Z-2592-2023 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.
