Sodium Chloride Inhalation Solution, USP, 0.7% 4 mL UDV (UOU)Recalls & reported problems
Ritedose Pharmaceuticals, LLC · Class 2
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 00376204021609), received between May 15, 2025 and May 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device 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.
InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A FEMALE PATIENT (UNSPECIFIED AGE) WHO WAS HOSPITALIZED FOR 3 DAYS TO RECEIVE IV ANTIBIOTICS, HAVING A HARD TIME TOLERATING THE SODIUM CHLORIDE INHALATION SOLUTION 7%. ON AN UNSPECIFIED DATE IN (B)(6) 2025, THE PATIENT-INITIATED TREATMENT WITH SODIUM CHLORIDE INHALATION SOLUTION, USP, 7%, (UNSPECIFIED DOSING DETAILS) TO TREAT REGARDING A MICRO-ORGANISM FOUND IN HER LUNGS. SHE REPORTED THAT SHE HAD HARD TIME TO TOLERATE SODIUM CHLORIDE INHALATION SOLUTION 7%. ON AN UNSPECIFIED DATE SHE WAS HOSPITALIZED FOR 3 DAYS AND RECEIVED INTRAVENOUS (IV) ANTIBIOTICS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. ACTION TAKEN WITH SODIUM CHLORIDE INHALATION SOLUTION AND THE OUTCOME OF THE EVENTS WAS NOT APPLICABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024472 ↗
Other Nebulizer (Direct Patient Interface) devices
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- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
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.
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