FDAFDA · Food and drugs·Recall number Z-1521-2024
AW-S035 NEO SONARMED SENSOR 3.5MM. 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-S035; UDI-DI: 10851334007206; Serial Numbers: A20221012, A20221019, A20221026, A20221109, A20221110, A20221111, A20221114, A20221212, A20221213, A20221214, A20221215, A20221216, A20230110, A20230111, A20230112, A20230113, A20230116, A20230130, A20230131, A20230202, A20230206, A20230306, A20230307.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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