Diasol, Inc: Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 lite
Read the official notice at FDA (device) →
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: 100325-10-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: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071
- Product quantity
- 74,400 gallons
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Phoenix
- State
- AZ
- Country
- United States
- Event id
- 97989
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