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Coolsculpting system - applicator - vacuum

Official notice

20 Jun 2022

MediumHealth Canada

An official Health Canada notice concerns Coolsculpting system - applicator - vacuum. Zeltiq Aesthetics, Inc. Is voluntarily discontinuing and recalling Coolsculpting parallel plate applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) due to the observance of a slightly increased rate of paradoxical hyperplasia during a recent analysis of data from the 2019-2021 timeframe. Recall start date: June 13, 2022 Published 2022-06-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64287

Official notice

2022-06-20

The hazard

Zeltiq Aesthetics, Inc. Is voluntarily discontinuing and recalling Coolsculpting parallel plate applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) due to the observance of a slightly increased rate of paradoxical hyperplasia during a recent analysis of data from the 2019-2021 timeframe. Recall start date: June 13, 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

64287

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Affected products

Product 1

Affected products - Coolsculpting System - Applicator - Vacuum, Lot or serial number - All lots., Model or catalog number - BRZ-AP1-063-000 BRZ-AP1-062-000 BRZ-AP1-066-000 BRZ-AP1-080-000 BRZ-AP1-064-000

Risk / hazard

Zeltiq Aesthetics, Inc. Is voluntarily discontinuing and recalling Coolsculpting parallel plate applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) due to the observance of a slightly increased rate of paradoxical hyperplasia during a recent analysis of data from the 2019-2021 timeframe. Recall start date: June 13, 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: AMD Medicom, Coolsculpting System - Applicator - Vacuum.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64287

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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