AirLife CHB0010Recalls & reported problems

Airlife · WATER STERILE IN HANGING BOTTLE 1000mL · Class 2

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 10190752141803), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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

Mechanical Problem1

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.

MalfunctionDec 10, 2024Mechanical Problem; Mechanical Problem
DRAINING ISSUES WITH INHALATION WATER BOTTLES, CAUSED OVER HEATING OF CIRCUIT BECAUSE WATER CHAMBER WENT DRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897976 ↗

Device details

UDI-DI	`10190752141803`
Brand	AirLife
Model	CHB0010
Company	Airlife
Product code	CAF · Nebulizer (Direct Patient Interface)
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 17, 2025

Device type (GMDN): Inhalation therapy sterile water

A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.

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