Recall Z-3002-2020— OraSure Technologies, Inc.

Name: FDA recall Z-3002-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-15

Class III · Terminated

Class III FDA medical device recall by OraSure Technologies, Inc., initiated 2020-07-15, terminated 2022-03-14. It names one FDA 510(k) clearance: K023487. Product: 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.. Reason: Unit boxes not properly sealed.

Recalling firm: OraSure Technologies, Inc.
Classification: Class III
Status: Terminated
Initiated: 2020-07-15
Terminated: 2022-03-14
Firm location: Bethlehem, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023487 — HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEOraSure Technologies, Inc.·cleared 2003-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Unit boxes not properly sealed

Data sourced from openFDA. This site is unofficial and independent of the FDA.