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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.
Nipro has received reports of one serious injury and one death.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Nipro at Nipro4621@sedgwick.com or 1-877-546-0126.
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