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U.S. Department of Health and Human Services

Class 1 Device Recall SonarMed AirWave

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  Class 1 Device Recall SonarMed AirWave see related information
Date Initiated by Firm March 21, 2024
Date Posted April 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-1519-2024
Recall Event ID 94292
510(K)Number K193058  
Product Classification airway monitoring system - Product Code OQU
Product AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
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.
Recalling Firm/
Manufacturer		 SonarMed Inc
12220 N Meridian St Ste 150
Carmel IN 46032-6972
For Additional Information Contact Technical Support
800-255-6774
Manufacturer Reason
for Recall		 The failure to detect the partial obstruction in a 2.5mm sensor.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 610 units
Distribution Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OQU and Original Applicant = SonarMed, Inc.
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