Date Recall Initiated |
June 24, 2005 |
---|---|
Product: |
Vail 500, Vail 1000 and Vail 2000 enclosed bed systems |
Use: |
These beds are used by hospitals, nursing homes and other caregivers for patients who have been identified as being at risk or in need of physical or chemical restraints. Patients typically using these beds have disorders such as cognitive impairment, unpredictable behavior, spasms, seizures and the potential to fall out of bed. |
Recalling Firm: |
Vail Products, Inc. 235 First Street Toledo, OH 43605-2041 |
Reason for Recall: |
Patients can become entrapped between the side-rail and the mattress or between the canopy and mattress of the Vail Products enclosed bed systems. This can result in severe neurological damage or death due to asphyxiation. |
Public Contact: |
Joy Vail Chief Executive Officer Vail Products, Inc. 235 First Street Toledo, OH 43605-2041 1-800-235-8245 |
FDA District: |
FDA District: Cincinnati |
FDA Comment: |
Hospitals, nursing homes and consumers who have a Vail enclosed bed system are advised to stop using it and move the patient to an alternate bed. Consumers who are using Vail beds at home can consult with their physicians about other options. If continued use of the Vail bed is the only option, users should follow these safety precautions recommended by Vail:
Additional recommendations for the Vail 1000 and 2000 models:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. |
For additional information, contact Vail Products, Inc., Customer Service Dept. at 1-800-235-8245 or visit the firm’s Web site at http://www.vailbed.com. FDA has updated the Public Health Notification it first issued on March 25, 2005 about the potential risk posed by these bed systems (http://www.fda.gov/cdrh/safety/032505-vail.html) to reflect the latest information on this problem. The FDA press release announcing the Vail recall is available at http://www.fda.gov/bbs/topics/NEWS/2005/NEW01194.html. |
Updated June 30, 2005
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