FDA Claims Vail Beds Cause Deaths, Seizes Products

The FDA has seized all Vail 500, 1000 and 2000 Enclosed Bed Systems from Toledo, OH-based Vail Products after the agency attributed seven deaths to malfunctions in the product. According to the agency, it is aware of approximately 30 entrapments in which the patient suffocated and resulted in severe neurological damage or death.

In response to the FDA’s actions, CEO Joy Vail wrote on the company’s website that she is standing behind the products. “We strongly believe that the government is wrong in suggesting that any Vail Enclosed Bed System is unsafe or that parents and others who are using an enclosed bed should stop using it,” said Vail.

The company also wrote on the site that there is no “substantiation” that the bed systems are the cause of the injuries and the fatalities.

In addition to the seizure and recall, the agency has collected all welded in-process components, labeling and promotional materials for those products. The FDA said it believed the products seized did not meet Quality System regulations and posed significant health risks for consumers.

Prior to the seizure, the FDA had sent two warning letters to the company to correct the violations, but the agency said there had not been an appropriate response.