FDAFDA · Food and drugs·Recall number Z-1520-2024
AW-S030 NEO SONARMED SENSOR 3.0MM. 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-2030; UDI-DI: 10851334007190; Serial Numbers: A20221012, A20221017, A20221024, A20221103, A20221115, A20221116, A20221117, A20221118, A20221130, A20221206, A20221222, A20221228, A20221229, A20230104, A20230111, A20230116, A20230117, A20230118, A20230208, A20230209, A20230313, A20230314, A20230315, A20230316, A20230317, A20230405.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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