Recall Z-2133-2019 ยท DQA Oximeter
Xhale Assurance, Inc.
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 vari
| Date | May 8, 2019 |
| Status | Terminated |
| Reason | These Instructions for Use has missing instructions related to the checking and changing of the application site procedure. |
| Root cause | Device Design |
| 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 |
| Quantity | 701,272 devices total |
| 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. |
| FDA record | Open on fda.gov |