SonarMed Inc: AW-S025 NEO SONARMED SENSOR 2.5MM. 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: 610 units Lot/code info: 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.

UPC codes

10851334007183

Source

Official record: FDA (Device enforcement) ↗

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