Citrasate 13-2251-CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101375), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 14, 2026Open, Classified

   Complaints of blue-green discoloration in product

   Z-3093-2026 · Root cause: Material/Component Contamination · 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.

• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A CLINIC AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT 9 DRUMS OF CITRASATE HAVE LOW CONDUCTIVITY. UPON FOLLOW UP, THE ATOM SAID THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.2 AND TCD 13.7. NO PATIENTS WERE DIALYZED USING THIS LOT. PER THE ATOM, THE CLINIC IS USING CITRISATE POWDER (LOT NUMBER UNKNOWN). PER THE ATOM, THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES AND THE CLINIC IS USING BIBAG BICARBONATE, LOT NUMBER UNKNOWN. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10906142 ↗