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TO: DMR Regional Directors, STS Director, CTH Coordinators, Private Providers
FROM: David N. Carlow , Director of Health and Clinical Services
DATE: March 28, 2005
RE: VAIL 500, 1000, and 2000 ENCLOSED BED SYSTEMS made By Vail Products Inc.

Please share this communication widely.

SAFETY ALERT

This SAFETY ALERT is to inform all agencies, agency personnel and others that the FDA (Food and Drug Administration) has advised consumers to stop using Vail 500, 1000, and 2000 Enclosed Bed Systems because this product poses a public safety risk because patients can become entrapped and suffocate, resulting in severe neurologic damage or death.

In addition the FDA advises consumers to stop using the Vail 500, 1000, and 2000 Enclosed Bed Systems until they receive additional instructions from Vail Products.

Please refer to these web sites for important information regarding this SAFETY ALERT: 
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01347.html
http://www.fda.gov/cdrh/safety/032505-vail.html