FDAFDA · Food and drugs·Recall number Z-2113-2012
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
Published August 8, 2012 · Recall initiated: June 26, 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
Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sunrise Medical (US) LLC
- Distributor
- Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
- Lot
- Receiver Product number 109207.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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