Device product
Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
Z-3003-2020
Product summary
- Event
- Event 86312
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23220 units
- Official record key
device-enforcement:Z-3003-2020
Official wording
Reason: Unit boxes not properly sealed
Code information: Lot Numbers: 9214, 9256
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Derived failure modes
-
Unknown
Unit boxes not properly sealed