VAIL ISSUES RECALL OF ENCLOSED BED SYSTEMS
Toledo, Ohio-based Vail Products is initiating a nationwide recall of approximately 5,000 "enclosed" bed systems that have been found to cause patient entrapments, resulting in severe neurological damage or death due to asphyxiation.
Under the terms of the recall, the company has sent new instruction manuals and warning labels to every customer informing them of the FDA's advice to stop using the bed system, move patients to alternative beds systems if possible and consult with their physician. Vail Products said 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.
At the request of the FDA in March, U.S. marshals seized all Vail 500, 1000 and 2000 enclosed bed systems manufactured because of entrapment and suffocation risks. Also seized were welded in-process components and all labeling and promotional material for the products.
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