Nasal Alar SpO2 Sensor (2019-05-08)
- Starting date:
- May 8, 2019
- Posting date:
- May 24, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-70031
Last updated: 2019-05-24
Affected Products
Nasal Alar SpO2 Sensor
Reason
To update instruction for use (IFU) to inform customers to check and change the application site. This information is missing from the Nasal Alar SpO2 Sensor (IFU) for revisions 10412_7 and prior.
Affected products
Nasal Alar SpO2 Sensor
Lot or serial number
Not applicable.
Model or catalog number
A1X-0303
Companies
- Manufacturer
-
XHALE ASSURANCE, INC.
3630 SW 47TH AVENUE, SUITE 100
Gainesville
Florida
UNITED STATES