BEUDAMED
    FDA Recall Open, Classified

    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    Recall: Z-1519-2024 · Initiated March 21, 2024

    Recall

    Recall Number
    Z-1519-2024
    Event Number
    94292
    Firm
    SonarMed Inc
    FEI Number
    3009923584
    Product Code
    OQU
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 21, 2024
    Posted
    April 18, 2024
    Address
    12220 N Meridian St, Ste 150, Carmel, IN, 46032-6972

    Description

    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    Reason

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

    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.

    Distribution

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

    Quantity

    610 units