Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FDA adverse event reports and recall history for dialysate concentrate for hemodialysis (liquid or powder) (product code KPO), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 30,014
- Deaths
- 23,081
- Injuries
- 5,346
- Malfunctions
- 1,495
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-10Open, ClassifiedProcess control
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
- 2026-09-10Open, ClassifiedProcess control
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Hemodialysis concentrates contain high endotoxin levels
- 2026-09-10Open, ClassifiedProcess control
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Hemodialysis concentrates contain high endotoxin levels
- 2026-09-10Open, ClassifiedProcess control
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Hemodialysis concentrates contain high endotoxin levels
- 2026-09-03Open, ClassifiedMaterial/Component Contamination
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Complaints of blue-green discoloration in product
- 2026-09-03Open, ClassifiedMaterial/Component Contamination
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Complaints of blue-green discoloration in product
- 2026-09-03Open, ClassifiedMaterial/Component Contamination
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Complaints of blue-green discoloration in product
- 2026-06-11Open, ClassifiedProcess control
Bicarby Dialysate; Model number: RFP-400-G;
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
- 2026-06-05Open, ClassifiedProcess design
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
- 2025-12-23Open, ClassifiedProcess design
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
Monitor dialysate concentrate for hemodialysis (liquid or powder) automatically
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