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U.S. Department of Health and Human Services

Class 2 Device Recall Advanta 2 Bed.

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 Class 2 Recall
Advanta 2 Bed.
see related information
Date Posted June 22, 2012
Recall Status1 Terminated on June 06, 2014
Recall Number Z-1864-2012
Recall Event ID 62331
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Code Information AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
1069 State Route 46 East
Batesville, Indiana 47006-7520
Manufacturer Reason
for Recall
During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.
FDA Determined
Cause 2
DESIGN: Process Design
Action Hill-Rom sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm. Contact Hill-Rom Technical Support at 800-445-3720 for questions regarding this notice.
Quantity in Commerce 7843 devices
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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