Health product recall

Restore Wound Cleanser

Last updated

Summary

Product
Restore Wound Cleanser
Issue
Medical devices - Unauthorised device
What to do

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
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies

Hollister Incorporated

2000 Hollister Drive, Libertyville, Illinois

United States, 60048

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63985