Gainesville, FL, United States
Xhale Assurance, Inc. recalls
1 recall recorded since 2018, most recently on 8 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 May 2019
- Terminated
- 25 April 2022
- Reason
- These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2133-2019
- 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 satura
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.