Grace Healthcare Medical, Inc. is recalling 35,838 cylinders of Compressed Medical Oxygen (USP UN 1072) because the manufacturing processes did not meet Current Good Manufacturing Practice (cGMP) standards. This recall affects various cylinder sizes, including M6, C, D, E, M, and H medical gas cylinders, that were distributed nationwide between April 2019 and April 2021. Because these quality control deviations may affect the purity or potency of the oxygen, patients should contact their healthcare provider immediately.
Failure to follow mandatory quality manufacturing standards (cGMP) can lead to the distribution of medical gases that are contaminated or do not meet purity specifications. For patients dependent on medical oxygen, using a product with substandard quality can lead to ineffective treatment or respiratory complications.
Contact healthcare provider and return product for refund.
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.