Health product recall

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