RecallDepth

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.

This recall has been terminated (originally issued December 28, 2010).

Company
Sunrise Medical Inc
Recall Initiated
February 2, 2009
Posted
December 28, 2010
Terminated
January 3, 2011
Recall Number
Z-0831-2011
Quantity
23
Firm Location
Fresno, CA
Official Source
View on FDA website ↗

Reason for Recall

The stabilizer bar was inadvertently omitted during the manufacturing process.

Distribution

Worldwide Distribution -- United States and Canada.

Lot / Code Info

Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.

Root Cause

Process change control

Action Taken

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.

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