Z-3001-2020 Class III Terminated
FDA device recall Z-3001-2020 was initiated by OraSure Technologies, Inc. on July 15, 2020 and is designated Class III. Reason for recall: Unit boxes not properly sealed The recall status is terminated (terminated March 14, 2022). Affected quantity: 23400 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- July 15, 2020
- Termination Date
- March 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23400 units
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Code Information
Lot Numbers: 9214, 9256