Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
FDA Recall Z-1864-2012 · Posted 2012-06-22
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2012-06-18
Date Terminated2014-06-06
Product Quantity7843 devices
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.