FDA Enforcement
Class I
Ongoing
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Recall: Z-1521-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1521-2024
- 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-S035 NEO SONARMED SENSOR 3.5MM. 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-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.
Distribution
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Quantity
500 units