Quick summary
Quick summary: Dabir System.
Public recall detail
Dabir System
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Dabir System.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandDabir Surfaces, Inc.
ProductDabir System
IssueMedical devices - Revised instructions for use
Recall classType II
IdentificationRA-63983
Affected products
ProductDabir Patient Care Plus System
Lot11210550002F
ModelC2-10V1
Serial number11210550002F
DescriptionDabir Patient Care Plus System
ProductDabir Patient Care Plus System
Lot11143530025F, 11150090006F
ModelCA-1000
Serial number11143530025F, 11150090006F
DescriptionDabir Patient Care Plus System
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesDabir Surfaces, Inc. 7447 West Wilson Avenue, Harwood Heights, Illinois United States, 60706
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63983
Background{}
CompaniesDabir Surfaces, Inc. 7447 West Wilson Avenue, Harwood Heights, Illinois United States, 60706
AudiencesGeneral public Health professionals Hospitals
Source updated2022-03-14
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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Product images
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