FDA seizes potentially deadly hospital beds
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The U.S. Food and Drug Administration, citing a risk of suffocation, said on Tuesday it ordered the seizure of enclosed hospital beds made by Vail Products Inc.
The FDA said it was aware of 30 people who became trapped in the beds, seven of whom died.
Officials at Toledo, Ohio-based Vail Products could not be immediately reached for comment.
The company’s Web site says the beds, used for clinical and home care, allow “the patient to move about freely within a safe, padded environment.”
The FDA said it directed U.S. marshals to seize all finished Vail 500, 1000, and 2000 enclosed beds as well as components, labeling and promotional materials for those models.
The agency said the beds are misbranded because they are dangerous when used as recommended in the labeling. They also lack adequate directions for use and adequate warnings, it said.
The FDA said Vail Products failed or refused to furnish requested information, and inspections show that the company has continually failed to follow quality requirements.
Revision date: June 20, 2011
Last revised: by Sebastian Scheller, MD, ScD
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