Fresenius Medical Care Holdings, Inc. is recalling approximately 18.2 million Stay Safe Caps due to a need for updated labeling. The recall involves Model No. 050-95012 with UDI-DI 00840861100835 across all lot numbers. The manufacturer is updating the product instructions to include additional warnings and contraindications regarding potential side effects that were not previously detailed. Consumers should contact their healthcare provider or the manufacturer to ensure they have the most current safety information.
The current labeling lacks comprehensive warnings and contraindications, which could lead to patients or caregivers being unaware of specific risks or side effects associated with the device's use.
Labeling update and safety 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
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