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Recall Observatory FDA recall evidence

Device 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.

Z-3003-2020

July 15, 2020

Class III

Product summary

Firm
OraSure Technologies, Inc.
Event
Event 86312
Status
Terminated
Classification
Class III
Quantity
23220 units
Official record key
device-enforcement:Z-3003-2020

Official wording

Reason: Unit boxes not properly sealed

Code information: Lot Numbers: 9214, 9256

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Unit boxes not properly sealed