CardinalHealth has recalled approximately 49.5 million Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve (ARV) can break when used improperly. This recall affects multiple sizes and models of the sterile stomach tubes, ranging from 12 Fr/Ch to 18 Fr/Ch, which were distributed nationwide and to government or military facilities. The firm initiated this recall to update the product labeling after receiving reports of the valves breaking. If you use these devices, you should review the updated instructions and contact your healthcare provider or the manufacturer for guidance.
The Anti-Reflux Valve component of the stomach tube can break if used incorrectly, which may cause the device to fail or potentially leave broken pieces within a patient's medical environment. This risk could lead to procedural delays or unintended patient injury during medical treatment.
Labeling changes and instructions for proper use.
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.