A Medical Device Daily
The FDA and the Department of Justice (DoJ) yesterday reported that they have initiated seizures of all finished Vail 500, 1000 and 2000 Enclosed Bed Systems made by Vail Products (Toledo, Ohio), calling the action "a response to ongoing concerns about manufacturing quality and labeling."
The FDA said it is aware of about 30 entrapments resulting from use of the Vail Enclosed Bed Systems, and that at least seven of those incidents had resulted in death.
Use of the Vail bed systems, the FDA and the DoJ said, poses a public health risk "because patients can become entrapped and suffocate, resulting in severe neurological damage or death."
The FDA said it is advising consumers to stop using the Vail 500, 1000 and 2000 Enclosed Bed Systems until they receive "additional instructions" from the company.
The U.S. Marshal's Office also seized welded in-process components and all labeling and promotional materials for the Vail 500, 1000 and 2000 products.
The FDA said it believes the Vail products seized "do not meet with the Quality System regulations of the Federal Food, Drug and Cosmetic Act and pose significant health risk for consumers."
And the agency said that the enclosed Bed Systems are misbranded because they are dangerous to health when used in the manner, or with the frequency or duration prescribed, recommended or suggested in the labeling. They are further misbranded because they lack adequate directions for use and adequate warnings, thereby placing patients at an increased risk of entrapment and asphyxiation.
Additionally, it said that Vail Products "failed or refused to furnish material or information to the FDA as required by Medical Device Reporting regulation and the Reports of Corrections and Removals regulation."
FDA inspections of Vail Products revealed that the firm has continually failed to follow the requirements of the Quality System regulation when manufacturing enclosed bed systems. Vail Products has previously received two FDA Warning Letters outlining unacceptable practices.
"The firm was given an opportunity to correct the violations, but failed to take appropriate actions," the agency said.