The Recall Desk
HighFDA (Devices)·Z-0989-2026·Announced 2025-12-31

[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

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.