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Restore wound cleanser
Official notice
14 Mar 2022
Last checked
14 Mar 2022
An official Health Canada notice concerns Restore wound cleanser. The product license is on hold/suspended due to the missing MDSAP certification from the supplier Biomed. Since there is no MDSAP certification the products are not meeting the regulatory requirements of the act or MDR for Health Canada (Medical Devices Recall Guide - GUI-0054, 2016). There is no defect or malfunction on these products. This is a compliance issue related to missing documentation required to commercialize products in Canada. Recall start date: Feb 15, 2022 Published 2022-03-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63985
Official notice
2022-03-14
The hazard
The hazard
The product license is on hold/suspended due to the missing MDSAP certification from the supplier Biomed. Since there is no MDSAP certification the products are not meeting the regulatory requirements of the act or MDR for Health Canada (Medical Devices Recall Guide - GUI-0054, 2016). There is no defect or malfunction on these products. This is a compliance issue related to missing documentation required to commercialize products in Canada. Recall start date: Feb 15, 2022
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Hollister, Restore Wound Cleanser.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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