SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

Recall date

March 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1521-2024

FDA classification

Class I

Brand / firm

SonarMed Inc

Sold / distributed

Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.