Medical Device
Manufacturing
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Z-0831-2011

Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and...

Sunrise Medical, Inc. / initiated 2009-02-02 / Terminated / root cause: manufacturing process

Sunrise Medical Inc began a recall of Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended... on . The reason FDA records is "The stabilizer bar was inadvertently omitted during the manufacturing process". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0831-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
Product
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.
Product code
IOR Wheelchair, Mechanical
Reason for recall
The stabilizer bar was inadvertently omitted during the manufacturing process.
Root cause tag
manufacturing process
FDA root cause
Process change control
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.
Quantity in commerce
23
Distribution
Worldwide Distribution -- United States and Canada.
Product codes and lots
Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.