SonarMed Inc: AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

Hazard

The failure to detect the partial obstruction in a 2.5mm sensor.

Details from the source

Reason for recall: The failure to detect the partial obstruction in a 2.5mm sensor. Distribution: Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA. Quantity: 690 units Lot/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.

UPC codes

10851334007190

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.