FDA Enforcement
Class I
Ongoing
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Recall: Z-1520-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1520-2024
- Event ID
- 94292
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SonarMed Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2024
- Initiation Date
- March 21, 2024
- Classification Date
- April 18, 2024
- Address
- 12220 N Meridian St Ste 150, Carmel, IN, 46032-6972, United States
Description
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason
The failure to detect the partial obstruction in a 2.5mm sensor.
Code Info
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.
Distribution
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Quantity
690 units