FDA recall Z-3003-2020

OraSure Technologies, Inc. · Class III · 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.

Reason for recall

Unit boxes not properly sealed

Distribution

Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.

Key facts

Status
Terminated
Initiation date
2020-07-15
Report date
2020-09-30
Termination date
2022-03-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3003-2020