AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
FDA device recall Z-1520-2024 · posted 2024-04-18 · Open, Classified
Recall details
- Recalling firm
- SonarMed Inc
- Reason for recall
- The failure to detect the partial obstruction in a 2.5mm sensor.
- Action taken
- An Urgent Medical Device Recall notification dated 3/25/2024 was mailed to consignees via UPS notifying them of this SonarMed Sensor recall. Consignees were asked to discontinue use of affected devices, quarantine any affected devices, and return all quarantined devices to Medtronic by obtaining a Returned Goods Authorization (RGA) from rs.covidienfeedbackcustomerservice@medtronic.com. If product was purchased through a distributor the distributor can arrange for return. The provided notification is to be provided to those within consignee organizations that need to be made aware and if product was further distributed. Consignees with questions are to contact customer service at 800-962-9888, Option 2.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OQU
- Quantity affected
- 690 units
- Distribution
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
- Date initiated
- 2024-03-21
- Date posted
- 2024-04-18
- Location
- Carmel, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SonarMed AirWave Airway Monitoring System (K193058) | Sonarmed, Inc. | 2020-05-15 |