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U.S. Department of Health and Human Services

Class 2 Device Recall Enclosed Canopy Beds

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 Class 2 Device Recall Enclosed Canopy Bedssee related information
Date Initiated by FirmApril 01, 2003
Date PostedJuly 17, 2003
Recall Status1 Terminated 3 on October 29, 2008
Recall NumberZ-1025-03
Recall Event ID 26504
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductVail Enclosed Bed System, model 1000
Code Information All serial numbers affected.
Recalling Firm/
Manufacturer		 Vail Products Inc
235 First St
Toledo OH 43605
For Additional Information Contact
419-698-3201
Manufacturer Reason
for Recall		Patients may become entrapped between the bottom side rail and mattress.
FDA Determined
Cause 2		Other
ActionThe firm notified the customers by mail in April 2003, and by telephone, fax, and mail on 6/30/2003.
Quantity in Commerce1,008 units
DistributionNationwide; Canada and Saudi Arabia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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