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U.S. Department of Health and Human Services

Class 2 Device Recall Diasol Acid Concentrate

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 Class 2 Device Recall Diasol Acid Concentratesee related information
Date Initiated by FirmNovember 05, 2025
Date PostedDecember 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0987-2026
Recall Event ID 97989
510(K)NumberK851431 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductBrand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
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
Recalling Firm/
Manufacturer		 Diasol, Inc
310 S 43rd Ave Ste B
Phoenix AZ 85009-4606
For Additional Information ContactMonica Abeles
1-602-4427670
Manufacturer Reason
for Recall		Safety and efficacy of dialysis acid concentrate cannot be assured
FDA Determined
Cause 2		Process design
ActionOn November 5, 2025, Diasol issued a "Urgent Medical Device Recall Notification to affected consignees. In addition to informing consignees about the recall, Diasol asked consignees to take the following actions: 1. Please return all product you have at your facility. 2. Please complete the attached acknowledgement form. 3. If product has been further distributed to other distributors, customer or sites, notify those consignees and provide them with a copy of the recall notification. 4. The notice should be provided to all staff members who use the product. 5. In the event you have not received adequate products from Rockwell you may continue to use Diasol Products at risk.
Quantity in Commerce186,000 containers
DistributionUS Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPO
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