Nipro Renal Solutions USA, Corporation is recalling 816,840 units of MedicaLyte Liquid Bicarbonate Concentrate (Model BC+201) and 39,228 units (Model BC+100) due to the potential presence of visible foreign matter. These products are plastic bottles used during dialysis treatments and are typically sold in cases of four bottles. No injuries or illnesses have been reported to date, but the company is initiating this voluntary recall as a safety precaution. Healthcare providers and clinical facilities should stop using the affected products immediately and contact the manufacturer or their distributor for a return or replacement.
Visible foreign matter in the bicarbonate concentrate could potentially enter the dialysis system, which may lead to serious health complications for patients undergoing treatment. While no incidents have been reported, the presence of contaminants in a medical fluid used for dialysis poses a critical safety risk.
Clinical / hospital medical device correction
Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824.
Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817.
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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