The Port O vent product experienced a FDA recall following initial product launch. Xinetix was contracted to investigate and resolve product performance and safety issues.
Xinetix immediately assembled a cross-functional team of R&D, Manufacturing, and RA/QA experts to address the recall. Team members conducted product user investigations to identify performance and safety issues. A quick turn product upgrades project was initiated resulting in redesign of internal reference regulation devices. An anti-asphyxiation valve designed and added to the system. Xinetix setup a pilot production facility in Irvine California to manufacture product used in clinical trials of the new design. Following clinical trials and FDA re-submission, Xinetix provided manufacturing engineering support for the product being manufactured with a contract manufacturer until the sale of the company in 2006.
In 2019 Xinetix was engaged by a new owner to address manufacturing issues and provide R&D for product line extensions.
