FDA Recall Terminated

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.

Recall: Z-2113-2012 · Initiated June 26, 2012

Recall

Recall Number
Z-2113-2012
Event Number
62493
Firm
Sunrise Medical (US) LLC
FEI Number
2937137
Product Code
IOR
Status
Terminated
Root Cause
Labeling design
Initiated
June 26, 2012
Posted
July 31, 2012
Terminated
November 1, 2012
Address
2842 N Business Park Ave, Fresno, CA, 93727-1328

Description

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.

Reason

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.

Action

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.

Distribution

Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.

Quantity

14, 035