Recall Z-3002-2020 ยท GEH Unit, Cryosurgical, Accessories
OraSure Technologies, Inc.
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
| Date | Jul 15, 2020 |
| Status | Terminated |
| Reason | Unit boxes not properly sealed |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 3000 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME OraSure Technologies, Inc., Mar 20, 2003 |