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.
This recall has been terminated (originally issued July 15, 2020).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- July 15, 2020
- Terminated
- March 14, 2022
- Recall Number
- Z-3002-2020
- Quantity
- 3000 units
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Numbers: 9214
Root 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.
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