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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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Event Detail

Event ID 62331
Product Type Devices
Status Ongoing
Recalling Firm Hill-Rom, Inc.
City Batesville
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital. AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403 Class II 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. 7843 devices Z-1864-2012