FDA Preliminary Public Health Notification*: Vail Products Enclosed Bed Systems
Updated: June 24, 2005
Original Date: March 25, 2005
originally published online at: http://www.fda.gov/cdrh/safety/032505-vail.html
Vail Products, Inc. of Toledo, Ohio, publicly stated on June 16, 2005, that it is permanently ceasing the manufacture, sale and distribution of all Vail enclosed bed systems. Vail Products will no longer be available to provide accessories, replacement parts, or retrofit kits. On June 23 and 24, 2005, revised instruction manuals and warning labels were mailed to customers with Vail 500, Vail 1000 or Vail 2000 enclosed bed systems. The revised manuals include new warnings, precautions, and instructions for use.
Recommendation for Users
Use of the Vail bed poses a public health risk because patients can become entrapped and suffocate, resulting in severe neurological damage or death. For this reason, FDA is advising hospitals, nursing homes and consumers who have a Vail enclosed bed system to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home can consult with their physicians about other options. (more…)