SonarMed Inc 2024-04-24 Health critical FDA
Health · FDA · Recall #FDA-Z-1519-2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway… Recall
Issued April 24, 2024 · SonarMed Inc
In April 2024, SonarMed Inc recalled the AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The failure to detect the partial obstruction in a 2.5mm sensor.
What you should do
- 1 Stop using AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SonarMed Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SonarMed Inc
- Category
- Health
- Recall date
- April 24, 2024
- Units affected
- Not reported
- Sold at
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
- Recall number
- FDA-Z-1519-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- SonarMed Inc has 3 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.