AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
FDA Recall #Z-1519-2024 — Class I — March 21, 2024
Product Description
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason for Recall
The failure to detect the partial obstruction in a 2.5mm sensor.
Recalling Firm
SonarMed Inc — Carmel, IN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
610 units
Distribution
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated