FDA Device recall Z-0992-2026
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- FDA Device
- Class II
- ongoing
- Published 2025-12-31
On 2025-12-31 the FDA classified a Class II recall of Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters by Diasol, citing safety and efficacy of dialysis acid concentrate cannot be assured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0992-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-05 |
| Published | 2025-12-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diasol |
| Distribution | US |
Product
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason
Safety and efficacy of dialysis acid concentrate cannot be assured
Identifiers
| code_info | UDI: None/Lot Code: PHV08042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2026%22
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