Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDVRecalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00376204300032), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Application Program Problem: Medication Error” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Application Program Problem: Medication Error1
Contamination /Decontamination Problem1
Manufacturing, Packaging or Shipping Problem1

Patient problems

Muscle Weakness/Atrophy1
Viral Infection1

Recent adverse event reports

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

InjuryMar 25, 2025Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Application Program Problem: Medication Error; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Application Program Problem: Medication Error
THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A 66-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED INFLUENZA, NO MUSCLE IN LEGS, HAD TO USE SOME OF THE HALF DOSES OF SODIUM CHLORIDE INHALATION SOLUTION 0.9% AND COMPLAINED THAT 85 VIALS OUT OF 100 VIALS IN THE PACKAGE WERE ONLY FILLED HALFWAY AND VIALS HAVE WATER BUBBLES. CO-SUSPECT PRODUCT INCLUDED BROM-PSE-DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE). ON (B)(6)2024, THE PATIENT PICKED UP HER PRESCRIPTION. ON AN UNSPECIFIED DATE IN (B)(6) 2024, THE PATIENT INITIATED THE SODIUM CHLORIDE INHALATION SOLUTION 0.9%, AS PRESCRIBED, THREE TIMES A DAY AND UP TO FOUR ADDITIONAL TIMES AS NEEDED FOR HER COPD. THE PATIENT HAD BEEN TAKING SODIUM CHLORIDE INHALATION SOLUTION 0.9% EVERY 8 TO 12 HOURS AS NEEDED FOR COPD/ EMPHYSEMA FOR SEVERAL YEARS. ON (B)(6)2024, THE PATIENT DISCOVERED THAT 85 OUT OF THE 100 VIALS IN THE PACKAGE WERE ONLY FILLED HALFWAY, RAISING CONCERNS ABOUT VOLUME INCONSISTENCIES. THE PATIENT NOTICED THE ISSUE AFTER REALIZING THAT THE VIALS WERE RUNNING OUT QUICKLY AND THAT WATER BUBBLES WERE INSIDE. IT WAS REPORTED THAT SHE HAD BEEN FEELING VERY ILL, REQUIRING A VISIT TO HER DOCTOR
Patient problems: Muscle Weakness/Atrophy; Viral Infection
MAUDE report 21686181 ↗

Device details

UDI-DI	`00376204300032`
Brand	Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV
Model	3 mL
Company	Ritedose Pharmaceuticals, LLC
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	Jan 12, 2022

Device type (GMDN): Inhalation therapy saline solution, isotonic

A sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused.

Other Nebulizer (Direct Patient Interface) devices

HUDSON RCI IPN049807
Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)
62 reports
Circulaire™ 0330
Sunmed, LLC · Nebulizer (Direct Patient Interface)
1 recall0 reports
I neb 00
Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)
3 deaths15 reports
VixOne 0209
Westmed, Inc. · Nebulizer (Direct Patient Interface)
13 reports
HUDSON RCI IPN040620
Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)
12 reports
HUDSON RCI IPN049808
Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)
6 reports
HUDSON RCI HUD05014
Medline Industries, Inc. · Nebulizer (direct patient interface)
6 reports
VixOne 0210
Westmed, Inc. · Nebulizer (Direct Patient Interface)
5 reports

All Nebulizer (Direct Patient Interface) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page