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Ultra Renew

FDA Recall #Z-0819-2018 — Class II — December 4, 2017

Recall #Z-0819-2018 Date: December 4, 2017 Classification: Class II Status: Terminated

Product Description

Ultra Renew

Reason for Recall

Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation

Recalling Firm

Accord Media, LLC — New York, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

524 units

Distribution

US Nationwide

Code Information

none

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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