Recall Z-2133-2019— Xhale Assurance, Inc.

Name: FDA recall Z-2133-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-08

Class II · Terminated

Class II FDA medical device recall by Xhale Assurance, Inc., initiated 2019-05-08, terminated 2022-04-25. It names 2 FDA 510(k) clearances: K171423, K143216. 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. Reason: These Instructions for Use has missing instructions related to the checking and changing of the application site procedure..

Recalling firm: Xhale Assurance, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-08
Terminated: 2022-04-25
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K171423 — Nasal Alar SpO2 SensorXhale, Inc.·cleared 2017-07-27
K143216 — Assurance Alar / Nasal SpO2 SensorXhale, Inc.·cleared 2015-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.