Dabir System
Brand(s)
Last updated
Summary
Product
Dabir System
Issue
Medical devices - Revised instructions for use
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or Serial Number | Model or catalog number |
|---|---|---|
| Dabir Patient Care Plus System | 11210550002F | C2-10V1 |
| Dabir Patient Care Plus System | 11143530025F, 11150090006F | CA-1000 |
Issue
The device was incorrectly classified by manufacturer as a class I medical device and is in fact a class II medical device, which requires a medical device licence. Health Canada provided guidance on classification on December 24, 2021.
Recall start date: Feb 14, 2022 and Mar 14, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Dabir Surfaces, Inc.
7447 West Wilson Avenue, Harwood Heights, Illinois
United States, 60706
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63983
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