FDAFDA · Food and drugs·Recall number Z-1864-2012
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Published July 4, 2012 · Recall initiated: June 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hill-Rom, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
- Lot
- AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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