Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination
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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. |
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Reason for Recall Nipro stated that they received reports of concerning visual irregularities in some product jugs. Returned units were sent to a third-party laboratory for analysis, where bacterial and fungal particles were identified. Risks associated with the use of contaminated dialysate includes infections, treatment disruptions, sepsis, and possible 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. Affected Product MedicaLyte Liquid Bicarbonate Concentrate – 45x Proportioning (BC+201)
What to Do On June 2, Nipro sent all affected customers an updated letter recommending the following actions:
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