Medical device recalls

OraSure Technologies, Inc. recalls Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cry…

Recall date
July 15, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3002-2020
FDA classification
Class III
Brand / firm
OraSure Technologies, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.

Why it was recalled

Unit boxes not properly sealed

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

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