FDA-Device2020-09-30Class III

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.

OraSure Technologies, Inc.
Hazard

Unit boxes not properly sealed

Sold states
Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Affected count
3000 units
Manufactured in
220 E 1st St, N/A, Bethlehem, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3002-2020

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