Reason for Recall
Safety and efficacy of dialysis acid concentrate cannot be assured
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Recall NumberZ-0989-2026ClassificationClass IIStatusOngoingCategorydeviceInitiated2025-11-05Reported2025-12-31DistributionUS Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Code InfoUDI: None/Lot Code: PHV08112,PHV10082Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.