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The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit.
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.