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.
FDA Recall Z-3003-2020 · Posted None
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Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2020-07-15
Date Terminated2022-03-14
Product Quantity23220 units
Reason for Recall
Unit boxes not properly sealed
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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