SenTec AG is recalling approximately 15,065 packages of various Membrane Changer components used with the Sentec Digital Monitoring System (SDMS). During the manufacturing process, extra material may have been left inside these devices, which can interfere with the system's ability to provide accurate medical measurements. These components include the Membrane Changer Single-Use, Reloadable, and Insert models distributed nationwide across the United States. Consumers and healthcare providers should identify affected units by checking the reference and lot numbers on the packaging.
An additional piece of material inside the membrane changer can negatively impact the device's measurement performance, potentially leading to inaccurate patient monitoring data that could affect clinical decisions.
Healthcare provider or manufacturer consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.