Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Summary
The FDA issued a Class II for Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bica by Diasol, Inc. Reason: Safety and efficacy of dialysis acid concentrate cannot be assured.
Details
Source
Device Recall
External ID
Z-0991-2026
Action Date
2025-12-31
Status
Ongoing
Category
device
Product Description
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Lot/Code Info: UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071
Quantity Affected: 74,400 gallons
Reason for Recall
Safety and efficacy of dialysis acid concentrate cannot be assured
Distribution
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-05
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 103 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diasol, Inc has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diasol, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diasol, Inc have FDA actions?
Diasol, Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0991-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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