[pending] MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bo
Pending LLM rewrite. Source: FDA_DEVICE Z-1730-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for the presence of visible foreign matter.
The recalled product
- Product
- MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
- Manufacturer
- Nipro Renal Soultions USA, Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821
- Bottle UDI-DI 00817411022817. Lot Numbers: N3C014
- N3C018
- N3F018
- N4C010
- N4C012
- N4E004
- N4L021
- N4L022
- N4L037
- N5A044.
Distribution
Distributed nationwide across the United States.
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