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Citrasate
Fresenius Medical Care Renal Therapies Group, LLC · Model 08-3251-CA · UDI-DI 00840861101351
KPO
Prescription
10
510(k) clearances
30,008
Adverse events (23,081 deaths)
106
Recalls
34
Facilities
Description
Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Case
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-11-05 | Diasol, Inc | Safety and efficacy of dialysis acid concentrate cannot be assured |
| 2025-04-28 | NxStage Medical Inc | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the p |
| 2025-04-11 | Nipro Renal Soultions USA, Corporation | Potential for the presence of visible foreign matter. |
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Get your free API keyRead the docsData 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.