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PrismaSATE

BAXTER INTERNATIONAL INC. · Model 106957 · UDI-DI 07332414066833

KPO Prescription

510(k) clearances

30,009

Adverse events (23,081 deaths)

113

Recalls

Facilities

Description

The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.

Recalls

Date	Firm	Reason
2026-08-05	Nipro Renal Soultions USA, Corporation	Hemodialysis concentrates contain high endotoxin levels
2026-08-05	Nipro Renal Soultions USA, Corporation	Hemodialysis concentrates contain high endotoxin levels
2026-08-05	Nipro Renal Soultions USA, Corporation	Hemodialysis concentrates contain high endotoxin levels
2026-08-05	Nipro Renal Soultions USA, Corporation	Hemodialysis concentrates contain high endotoxin levels
2026-07-14	Fresenius Medical Care Renal Therapies Group, LLC	Complaints of blue-green discoloration in product
2026-07-14	Fresenius Medical Care Renal Therapies Group, LLC	Complaints of blue-green discoloration in product
2026-07-14	Fresenius Medical Care Renal Therapies Group, LLC	Complaints of blue-green discoloration in product
2026-05-12	Fresenius Medical Care Holdings, Inc.	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-
2026-05-07	Fresenius Medical Care Holdings, Inc.	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 pro
2025-11-05	Diasol, Inc	Safety and efficacy of dialysis acid concentrate cannot be assured

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.