TOLEDO, Ohio--U.S. Marshals have seized Vail Products' enclosed
beds, which the Food and Drug Administration says have trapped and
The FDA ordered the seizure of the Vail 500, 1000 and 2000
Enclosed Bed Systems on March 22, claiming the products pose a
public health risk, are misbranded and lack adequate warnings and
directions. FDA is aware of approximately 30 entrapments resulting
from the use of the bed systems, of which at least seven resulted
in death, according to an agency Preliminary Public Health
Vail refuted the claims on the company's Web site. "We strongly
believe that the government is wrong in suggesting that any Vail
Enclosed Bed System is unsafe or that parents and others who are
using an enclosed bed should stop using it," CEO Joy Vail wrote.
"For many vulnerable patients ... the alternative of falling out of
bed or wandering off is a real and everyday risk."
The canopy-like padded beds--for institutional and home care
use--are covered with nylon netting that is zipped into place to
reduce falls or prevent patients from wandering. They are used for
at-risk patients, both adults and children, with cognitive
impairment, unpredictable behavior, spasms, seizures and other
According to the FDA, patients can become trapped between the
side rails and mattress, between the mattress and canopy in places
where the rails do not extend and areas between the end rails and
mattress. Furthermore, the FDA said "the bed systems are misbranded
because they lack adequate directions for use and warnings, thereby
placing patients at an increased risk of entrapment and
asphyxiation." The agency is advising hospitals, nursing homes and
consumers to stop using the beds immediately.
If continued use of the beds is the only option, Vail has
recommended further safety precautions. The company said it has
voluntarily suspended shipment of the products since March 1.
For further details on the seizure, see FDA's Talk Paper on the
FDA Web site, available by clicking
For additional product updates and information, check www.vailbed.com or call Vail Products'
customer service department at (800) 235-8245.