STEVENSVILLE, Md., Jan. 4 /PRNewswire/ -- Vapotherm, Inc. announced
today that its 2000i High Flow Humidification Device has been reintroduced
to the market after agreement by the U.S. 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
"Vapotherm is pleased to return the 2000i and High Flow Therapy to our
users," said Robert Storey, President and CEO. Over the last five 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 website at
http://www.vtherm.com/customers/education.asp?section=1 For additional
information or to schedule an in-service session, please email
Vapotherm, Inc. is a privately held manufacturer of respiratory care
devices for hospitals and home care use based in Stevensville, Maryland.
The Company is dedicated to the development of innovative, non-invasive
technologies for respiratory therapy especially for the treatment of
chronic lung and acute breathing disorders. For more information, call
(410) 604-3977 or visit http://www.vtherm.com.
CONTACT: Kevin Thibodeau of Vapotherm, Inc., +1-410-604-3977, Fax:
SOURCE Vapotherm, Inc.