Device product
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0987-2026
Product summary
- Firm
- Diasol, Inc
- Event
- Event 97989
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 186,000 containers
- Official record key
device-enforcement:Z-0987-2026
Official wording
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Code information: 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
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