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Diasol, Inc: Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 lite

Medical DevicesSource: FDA (device) · Date: 2025-12-31

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Diasol, Inc
Product
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason / hazard
Safety and efficacy of dialysis acid concentrate cannot be assured
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Recall initiated
2025-11-05
Code info
UDI: None; Lot Code: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131
Product quantity
186,000 containers
Voluntary mandated
Voluntary: Firm initiated
City
Phoenix
State
AZ
Country
United States
Event id
97989
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