Recall Z-3001-2020
OraSure Technologies, Inc. · initiated July 15, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot Numbers: 9214, 9256
Reason for recall
Unit boxes not properly sealed
FDA-determined cause: Under Investigation by firm
Action taken
Orasure notified Distributors via email on 6/26/20 of the action to take re: the unsealed boxes. Rework to be performed by foreign Distributors and US product to be returned to the manufacturer for rework or scrap.
Details
- Recall number
- Z-3001-2020
- Initiated
- July 15, 2020
- Terminated
- March 14, 2022
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Quantity
- 23400 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
- Recalling firm
- OraSure Technologies, Inc., Bethlehem, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3002-2020 Class III | Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage:…Unit boxes not properly sealed | 07/15/2020Terminated |
| Z-3003-2020 Class III | Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 -…Unit boxes not properly sealed | 07/15/2020Terminated |