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Recall Observatory FDA recall evidence

Device product

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Z-0991-2026

November 05, 2025

Class II

Product summary

Firm
Diasol, Inc
Event
Event 97989
Status
Ongoing
Classification
Class II
Quantity
74,400 gallons
Official record key
device-enforcement:Z-0991-2026

Official wording

Reason: Safety and efficacy of dialysis acid concentrate cannot be assured

Code information: UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071

Distribution pattern: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Safety and efficacy of dialysis acid concentrate cannot be assured