NaturaLyte 08-3201-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840861101726), received between Nov 25, 2020 and Dec 1, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOTS OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS 13.0. NO PATIENTS WERE TREATED WITH THE LOTS. PER THE BIOMED, 10 CASES ARE AFFECTED AND NOW THEY ARE USING NATURALYTE LOT 20LXAC086. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES, AND THAT THEY USE BICARBONATE NATURALYTE 4000RX12, LOT NUMBER KNOW UNKNOWN. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10928427 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  THE REPORTED BATCH WAS ONE OF THE BATCHES LISTED ON A CLINIC NOTIFICATION REGARDING BATCHES SUSPECTED FOR LOW CONDUCTIVITY ISSUES. ALTHOUGH CONDUCTIVITY ISSUES WERE NOT ALLEGED, AS A PRECAUTION, CONDUCTIVITY WAS INVESTIGATED FOR THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10906206 ↗