Xhale Assurance Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage recall — FDA Z-2133-2019
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Overview of recall records associated with Xhale Assurance, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
This page summarizes recall records in which the official source identifies Xhale Assurance, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.