The U.S. Food and Drug Administration (FDA) has ordered the seizure of enclosed hospital beds made by Vail Products Inc. after 30 people became trapped in the beds; seven of these have died. The beds apparently pose a risk of suffocation.
The FDA says the beds are misbranded because they are dangerous when used as recommended in the labelling, lack adequate directions for use and inadequate warnings.The company's Web site says the beds, which are recommended for clinical and home care use, allow "the patient to move about freely within a safe, padded environment."
The FDA has directed U.S. marshals to seize all finished Vail 500, 1000, and 2000 enclosed beds as well as components, labelling and promotional materials for those models. Vail Products failed or refused to furnish requested information, and inspections show that the company has continually failed to follow quality requirements. Officials at Toledo, Ohio-based Vail Products could not be immediately reached for comment.