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MedicaLyte Liquid Bicarbonate Concentrate
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MEDICAL DEVICE RECALLMODERATE

MedicaLyte Liquid Bicarbonate Concentrate

Nipro recalls MedicaLyte hemodialysis concentrate (REF BC-100, BC+201) over high endotoxin levels.

What to do

Stop using the recalled MedicaLyte Liquid Bicarbonate Concentrate immediately and contact Nipro Renal Solutions for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Agency
FDA
Firm
Nipro Renal Soultions USA, Corporation
Recall ID
99573
Status
ONGOING

Why it was recalled

Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate (REF: BC-100 and BC+201) because the hemodialysis concentrates contain high endotoxin levels, which can cause fever, chills, and other serious reactions in patients.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot code
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)N4J030, Exp.9, 2026, N5D043, Exp.4, 2027, N6A025, Exp.1, 2028
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201N4L022, exp.11, 2026, N4L037, 201, N4L010
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))NDB5E004, exp.4, 2027, 201-25, NDB5M011, Exp.12, NDB4J003, exp.9, 2026
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25NDC5E015, Exp.5, 2027, NDC5E016, NDC5E017, NDC5E019, NDC5E012, NDC5B017, Exp.2, NDC5C023, Exp.3, 203-25, NDC5C026, NDC5L026, Exp.11

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification