SonarMed Inc Recall 94292
Description: AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc Recall 94292 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1521-2024 |
Event ID | 94292 |
Event Description | AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring. |
Product Type | Devices |
Distribution | Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA. |
Quantity | 500 units |
Recall Reason | The failure to detect the partial obstruction in a 2.5mm sensor. |
Device Classification | 20240424 |
Device 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. |
Center Classification Date | 20240418 |
Recall Initiation Date | 20240321 |
Recalling Firm | SonarMed Inc |
Initial Notification | Letter |
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