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Finger Pulse Oximeter
- Starting date:
- July 17, 2017
- Posting date:
- August 14, 2017
- 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-64170
Reason
The baseline fingertip pulse oximeters were not licensed in accordance with the Canadian medical device regulations.
Affected products
Finger Pulse Oximeter
Lot or serial number
- all lots
- all lots
Model or catalog number
- 12-1926
- 12-1926
- 12-1927
- 12-1927
Companies
- Manufacturer
-
Fabrication Enterprises, Inc.
P.O. Box 1500
White Plains
10602
New York
UNITED STATES