NaturaLyte 08-0231-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101610), received between Dec 6, 2021 and Dec 6, 2021 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 4, 2022Class IIOpen, Classified

   The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

   Z-0181-2023 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FRESENIUS BECAME AWARE (VIA AN ARTICLE IN THE JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY) THIS PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED (DATE NOT PROVIDED) DUE TO DEPRESSION AND SUICIDAL IDEATIONS. FURTHER REVIEW OF THE ARTICLE ENTITLED ¿CAUSTIC INJURY AFTER INGESTION OF NATURALYTE,¿ REVEALED THE PATIENT PRESENTED TO THE HOSPITAL WITH HYPERTENSION (235/142) AND AGITATION. HEMATOLOGICAL STUDIES DETERMINED THE PATIENT¿S POTASSIUM WAS 3.7 MMOL/L, AND HIS BICARBONATE WAS 25 MMOL/L. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT TO UNDERGO HD THERAPY, AND DURING SETTING UP, THE PATIENT INTENTIONALLY INGESTED 100 ML OF NATURALYTE TO INFLICT SELF-HARM. IMMEDIATELY AFTER INGESTING THE SOLUTION, THE PATIENT BEGAN TO VOMIT. THE PATIENT WAS EMERGENTLY PLACED ON HD, AND LABORATORY STUDIES INDICATED HIS K+ = 4.1 MMOL/L, PH (VENOUS) = 7.4, AND CO2 = 20 MMOL/L. ALTHOUGH THE EXACT TIMELINE IS UNKNOWN, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WHICH REVEALED ESOPHAGITIS AND STOMACH ULCERATION. THE PATIENT WAS REPORTEDLY TREATED WITH PANTOPRAZOLE AND A SUBSEQUENT EGD INDICATED THE PATIENT WAS RECOVERING. THE ART

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; High Blood Pressure/ Hypertension; Vomiting

  MAUDE report 12934204 ↗