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Xhale Assurance, Inc. recalls Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor i
Recalled August 7, 2019 · FDA recall Z-2133-2019 · Xhale Assurance
Hazard
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure. · FDA Class II
Units
701,272 devices total
Sold at
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.
Description
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Product
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
Manufacturer(s)
Xhale Assurance, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →