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Open, Classified

AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

FDA Recall Z-1520-2024 · Posted 2024-04-18

Recalling FirmSonarMed Inc
Recall StatusOpen, Classified
Product CodeOQU
Date Initiated2024-03-21
Product Quantity690 units

Reason for Recall

The failure to detect the partial obstruction in a 2.5mm sensor.

Firm 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 [email protected]. 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

Distribution Pattern

Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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