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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 OTCsee related information
Date Initiated by FirmJuly 15, 2020
Create DateSeptember 23, 2020
Recall Status1 Terminated 3 on March 14, 2022
Recall NumberZ-3003-2020
Recall Event ID 86312
510(K)NumberK023487 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductPointts 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 ContactSAME
610-882-1820
Manufacturer Reason
for Recall		Unit boxes not properly sealed
FDA Determined
Cause 2		Under Investigation by firm
ActionOrasure 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 Commerce23220 units
DistributionWorldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEH
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