Level 1 IR-500Recalls & reported problems

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20695085450006), received between Jan 20, 2025 and Jan 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
GCM RECEIVED AN EMAIL ON 31-DEC-2024 VIA SERVICE CLOUD FROM (B)(6) , A COMPLAINT COORDINATOR FROM MEDLINE INDUSTRIES, LP ON BEHALF OF (B)(6). THIS IS REGARDING AN IRRIGATION SET 10/CA WITH LIST NUMBER IR-500 AND LOT NUMBER 6027260. PRODUCT WAS MANUFACTURED ON 25-JUN-2024 AND WILL EXPIRE ON 25-JUN-2028 AND HAS A PURCHASE ORDER NUMBER OF 4517960583. IT WAS STATED IN THE REPORT THAT THEIR CUSTOMER HAS HAD LEAKING ISSUES WITH THIS PRODUCT. SAMPLES OF THE DEFECTIVE PRODUCT ARE AVAILABLE FOR INVESTIGATION. STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS UNKNOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT WAS BEING REPORTED. CRASONABLE (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21191149 ↗

Device details

UDI-DI	`20695085450006`
Brand	Level 1
Model	IR-500
Company	Icu Medical, Inc.
Product code	LGZ · Warmer, thermal, infusion fluid
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 16, 2025

Device type (GMDN): Heat-exchanging intravenous administration set

A collection of noninvasive devices designed to directly warm and conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It does not include devices intended to be used invasively. This is a single-use device.

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All Warmer, thermal, infusion fluid devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.