Restore Wound Cleanser
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Restore Wound Cleanser |
Not applicable. |
529975, 529976 |
Issue
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
Additional information
Details
Hollister Incorporated
2000 Hollister Drive, Libertyville, Illinois
United States, 60048
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