Vapotherm Inc, Stevensville, Md, has announced that its 2000i high-flow humidification device has been reintroduced to the market after agreement by the US Food and Drug Administration (FDA) that the company can begin shipping the devices to customers. The company is notifying its hospital and homecare customers to arrange for shipment of devices beginning this week.
The devices are being returned to customers with new instructions for use, including the recommendation to utilize only sterile water in the system.
“Vapotherm is pleased to return the 2000i and high flow therapy to our users,” said Robert Storey, President and CEO of Vapotherm. Over the 5 years, the device has become a new standard of care in neonatal, pediatric and adult respiratory therapy. During the recall period, we received a tremendous outpouring of support from health care practitioners, patients and their families, all voicing the importance of this technology in providing non-invasive respiratory support. We extend our sincere appreciation to our customers and partners for their patience and support during this period.”
Complete information on the corrective actions, recall, product operation and safety is available on the Vapotherm 2000i Reintroduction Information Web site at http://www.vtherm.com/customers/education.asp?section=1
For additional information or to schedule an in-service session, please email [email protected]