SonarMed Inc Recall 94292
Description: AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc Recall 94292 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1519-2024 |
| Event ID | 94292 |
| Event Description | AW-S025 NEO SONARMED SENSOR 2.5MM. 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 | 610 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-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. |
| Center Classification Date | 20240418 |
| Recall Initiation Date | 20240321 |
| Recalling Firm | SonarMed Inc |
| Initial Notification | Letter |
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