U.S. marshals seized adulterated and misbranded hospital bed systems manufactured by Vail Products, Toledo, Ohio, at the request of the Food and Drug Administration in response to ongoing concerns about manufacturing quality and labeling, the FDA said. The seizure encompassed all Vail 500, 1000 and 2000 enclosed bed systems, which the FDA said can entrap and suffocate patients, resulting in severe neurological damage or death. The agency said it is aware of approximately 30 such events, at least seven of them resulting in death.
Clients were advised to stop using such systems until they received additional instructions from Vail Products. An FDA spokeswoman said she did not know how many bed systems were seized. Marshals also seized welded components and all labeling and promotional materials for the products. Vail previously received two FDA warning letters outlining unacceptable practices and was given an opportunity to correct the violations, but failed to do so, officials said. An answering machine at Vail reported that the office is closed for the Easter holiday. -- by Cinda Becker