Medical Device Recalls
Class I Recall: Vail Products, Inc.
Enclosed Bed Systems

June 24, 2005

Hospitals, nursing homes and consumers who have a Vail enclosed bed system are advised 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.

If continued use of the Vail bed is the only option, users should follow these safety precautions recommended by Vail:

• Use these beds only for patients who are at least 45 inches tall and who weigh at least 46 lbs. Do not use the beds for patients smaller than this.
• Do not use these beds for patients who exhibit burrowing behavior; who are violent, aggressive, combative, or suicidal; who have multiple lines; or who have excessive PICA eating disorder.
• Use only the mattress recommended by the manufacturer to reduce the possibility of entrapment between the bed rails and the mattress.
• Always leave the side rails in the “Up” and locked position, except when you are providing patient care or moving the patient from the bed.
• Always return the bed to the flat position while the patient is unattended, unless head elevation has been ordered by a physician.
• Keep all canopy sides zipped and locked at all times. Never leave a patient unattended while the cover is unzipped.

Additional recommendations for the Vail 1000 and 2000 models:

• Never leave the Hi-Lo feature in the high position while the patient is unattended. The Hi-Lo feature allows the entire bed sleep surface to be raised and lowered. When the bed is in the “Hi” position, the risk of entrapment is increased.
• If you have received a retrofit kit, make sure it is properly installed. Although the retrofit kit is intended to reduce the risk of entrapment, its effectiveness was never validated by the manufacturer. The FDA has no assurance that the retrofit kits will adequately reduce the risk of entrapment and is aware of at least four entrapments, including two deaths, that occurred with the kit installed.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

For additional information, contact Vail Products, Inc., Customer Service Dept. at 1-800-235-8245 or visit the firm’s Web site at http://www.vailbed.com.

FDA has updated the Public Health Notification it first issued on March 25, 2005 about the potential risk posed by these bed systems (http://www.fda.gov/cdrh/safety/032505-vail.html) to reflect the latest information on this problem. The FDA press release announcing the Vail recall is available at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01194.html.