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U.S. Department of Health and Human Services

Class 3 Device Recall Pointts sistema de ellmlnact!;o de verrugas OTC

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  Class 3 Device Recall Pointts sistema de ellmlnact!;o de verrugas OTC see related information
Date Initiated by Firm July 15, 2020
Create Date September 23, 2020
Recall Status1 Terminated 3 on March 14, 2022
Recall Number Z-3003-2020
Recall Event ID 86312
510(K)Number K023487  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
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.
Code Information Lot Numbers: 9214, 9256
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
220 E 1st St
Bethlehem PA 18015-1360
For Additional Information Contact SAME
610-882-1820
Manufacturer Reason
for Recall		 Unit boxes not properly sealed
FDA Determined
Cause 2		 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 in Commerce 23220 units
Distribution Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = ORASURE TECHNOLOGIES, INC.
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