Fresenius Medical Care Holdings is recalling 53,424 bags of Sodium Chloride 0.9% Injection, USP (saline), in the 1000 mL size. This recall was initiated because the product was potentially exposed to storage temperatures below the recommended range, which may cause the packaging to leak. No injuries or illnesses have been reported in connection with this issue.
Leaking packaging can lead to a loss of sterility in the saline solution. Using a non-sterile injectable product poses a serious risk of infection, which can lead to severe health complications or life-threatening conditions for patients.
Recall #: D-0777-2023
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 ยท 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.