Recall Z-2113-2012
Sunrise Medical (US) LLC · initiated June 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Receiver Product number 109207.
Reason for recall
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.
FDA-determined cause: Labeling design
Action taken
Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.
Details
- Recall number
- Z-2113-2012
- Initiated
- June 26, 2012
- Posted by FDA
- July 31, 2012
- Terminated
- November 1, 2012
- Product code
- IOR – Wheelchair, Mechanical
- Quantity
- 14, 035
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
- Recalling firm
- Sunrise Medical (US) LLC, Fresno, CA