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
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
Safety and efficacy of dialysis acid concentrate cannot be assured