FDA Recall Terminated

Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.

Recall: Z-0831-2011 · Initiated February 2, 2009

Recall

Recall Number
Z-0831-2011
Event Number
51260
Firm
Sunrise Medical Inc
FEI Number
2937137
Product Code
IOR
Status
Terminated
Root Cause
Process change control
Initiated
February 2, 2009
Posted
December 28, 2010
Terminated
January 3, 2011
Address
2842 N Business Park Ave, Fresno, CA, 93727-1328

Description

Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.

Reason

The stabilizer bar was inadvertently omitted during the manufacturing process.

Action

An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.

Distribution

Worldwide Distribution -- United States and Canada.

Quantity

23