AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- SonarMed Inc
- Reason for Recall:
- The failure to detect the partial obstruction in a 2.5mm sensor.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1519-2024
Related Recalls
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
SonarMed
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed
The failure to detect the partial obstruction in a 2.5mm sensor.
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed
The failure to detect the partial obstruction in a 2.5mm sensor.