BEUDAMED
    FDA Recall Terminated

    Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision

    Recall: Z-2133-2019 · Initiated May 8, 2019

    Recall

    Recall Number
    Z-2133-2019
    Event Number
    82817
    Firm
    Xhale Assurance, Inc.
    FEI Number
    1000113495
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 8, 2019
    Terminated
    April 25, 2022
    Address
    3630 Sw 47th Ave, Ste 100, Gainesville, FL, 32608-7555

    Description

    Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision

    Reason

    These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

    Action

    Xhale Assurance, Inc. notified consignees on about 05/08/2019, via "URGENT - Medical Device Correction" letter. Customers were instructed to insert the IFU Addendum into each case of sensors for ready reference, review all information provided in the updated IFU Addendum with all members of your staff whom need to be aware of the updated instructions, and complete and return the provided Customer Reply Form. Distributors were instructed to insert the IFU Addendum into each case of sensors for ready reference, provide a copy of the Field Safety Notice and IFU Addendum to any customer to whom affected devices have been distributed to, and complete and return the provided Customer Reply Form.

    Distribution

    US Nationwide distribution to AZ, CA, FL, KS, LA, MA , MO, MS, NC, NY, OH, PA, TX, WI. International distribution to Canada, Germany, Malaysia, United Kingdom.

    Quantity

    701,272 devices total