SonarMed Inc: AW-S035 NEO SONARMED SENSOR 3.5MM. 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: 500 units Lot/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.

UPC codes

10851334007206

Source

Official record: FDA (Device enforcement) ↗

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