Recall Z-3001-2020— OraSure Technologies, Inc.

Name: FDA recall Z-3001-2020
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: CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.. 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

CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.

Reason for recall

Unit boxes not properly sealed

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