*Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination* The U.S. Food and Drug Administration is aware that Nipro has issued a letter to affected customers recommending all lots of MedicaLyte Liquid Bicarbonate Concentrate be removed from where they are used or sold due to reports of contamination. Nipro received reports of concerning visual irregularities in some product jugs. Returned units were sent to a third-party laboratory where bacterial and fungal particles were identified through analysis. Risks associated with the use of contaminated dialysate includes infections, treatment disruptions, sepsis, and potential death. Potential long-term health consequences include chronic infections which may cause or contribute to organ damage and a weakened immune system. If the contaminated product is used, the hemodialysis machine will need to be disinfected following the dialysis machine manufacturer’s recommendations. https://www.fda.gov/medical-devices/medical-device-recalls/liquid-bicarbonate-concentrate-recall-nipro-removes-medicalyte-liquid-bicarbonate-concentrate-due?utm_medium=email&utm_source=govdelivery