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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62493
Product Type Devices
Status Ongoing
Recalling Firm Sunrise Medical (US) LLC
City Fresno
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Receiver Product number 109207. Class II 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. 14, 035 Z-2113-2012