No image published for this recall

No image published for this recall

Restore wound cleanser

Official notice

14 Mar 2022

Last checked

14 Mar 2022

Medium riskHealth Canada

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 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

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63985

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Affected products

Product 1

Affected Products - Restore Wound Cleanser, Lot or Serial Number - Not applicable., Model or catalog number - 529975, 529976

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Hollister, Restore Wound Cleanser.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

63985

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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