Health product recall

Dabir

Last updated

Summary

Product
Dabir
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: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - 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