AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
This recall is currently active, issued April 18, 2024. It was issued by Sonarmed Inc.
- Company
- Sonarmed Inc
- Recall Initiated
- March 21, 2024
- Posted
- April 18, 2024
- Recall Number
- Z-1519-2024
- Quantity
- 610 units
- Firm Location
- Carmel, IN
- Official Source
- View on FDA website ↗
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.
Lot / 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.
Root Cause
Process control
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.