FDA recall Z-1520-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-03-21

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carmel, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2024