Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV 4 mLRecalls & 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 00376204022606), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Fungal Infection1
- Itching Sensation1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A 61-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED REPETITIVE STREPTOCOCCUS IN THE LUNGS, SKIN BREAK OUT FROM CHEST, ALWAYS ITCH AFTER SODIUM CHLORIDE TREATMENT/ITCHING, REPETITIVE THRUSH, AND BACTERIAL INFECTION IN THE MOUTH COINCIDENT WITH SODIUM CHLORIDE INHALATION SOLUTION 3%. IN (B)(6) 2024 (UNKNOWN EXACT DATE), THE PATIENT INITIATED THE SODIUM CHLORIDE INHALATION SOLUTION FOR COLLAPSED LUNGS. IT WAS REPORTED THAT SHE WAS ORIGINALLY ON SODIUM CHLORIDE INHALATION SOLUTION 3% BUT WAS GIVEN 7% DUE TO THE MEDICATION BEING OUT OF STOCK FOR A WEEK. IMMEDIATELY AFTER STARTING SODIUM CHLORIDE INHALATION SOLUTION, THE PATIENT EXPERIENCED A SKIN BREAKOUT OUT FROM THE CHEST AND ITCHING. SHE MENTIONED THAT SHE ALWAYS EXPERIENCED ITCH AFTER SODIUM CHLORIDE TREATMENT. THE PATIENT WAS ALSO PLACED ON POSACONAZOLE FOR ONLY THREE MONTHS STARTING FROM (B)(6) 2024. THE PATIENT STATED THAT SHORTLY AFTER STARTING THE MEDICATION, SHE WAS GETTING REPETITIVE STREPTOCOCCUS IN THE LUNGS AND HAD BEEN HOSPITALIZED (UNKNOWN DATE) AND RECEIVED INTRAVENOUS ANTIBIOTICS AS TREATMENT (DATE UNKNOWN). IN (B)(6) 2024, THE PATIENT STATED THAT SHE STARTED EXPE
Patient problems: Bacterial Infection; Fungal Infection; Itching Sensation; Rash
MAUDE report 21371205 ↗
Other Nebulizer (Direct Patient Interface) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page