FDAFDA · Food and drugs·Recall number Z-1519-2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Published April 24, 2024 · Recall initiated: March 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The failure to detect the partial obstruction in a 2.5mm sensor.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SonarMed Inc
- Distributor
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
- Lot
- Product Number/CFN: AW-S025; UDI-DI: 10851334007183; Serial Numbers: A20221012, A20221018, A20221025, A20221107, A20221109, A20221202, A20221206, A20221207, A20221208, A20221209, A20230105, A20230109, A20230123, A20230124, A20230125, A20230126, A20230213, A20230224, A20230228, A20230301, A20230302, A20230303, A20230320, A20230324, A20230411, A20230724, A20230725.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.