[pending] Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non
Pending LLM rewrite. Source: FDA_DEVICE Z-0989-2026.
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
Safety and efficacy of dialysis acid concentrate cannot be assured
The recalled product
- Product
- Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Manufacturer
- Diasol, Inc
- 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 (2)
- UDI: None/Lot Code: PHV08112
- PHV10082
Distribution
Distributed nationwide across the United States.
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