Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Su
FDA device recall Z-0831-2011 · posted 2010-12-28 · Terminated
Recall details
- Recalling firm
- Sunrise Medical Inc
- Reason for recall
- The stabilizer bar was inadvertently omitted during the manufacturing process.
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 23
- Distribution
- Worldwide Distribution -- United States and Canada.
- Date initiated
- 2009-02-02
- Date posted
- 2010-12-28
- Date terminated
- 2011-01-03
- Location
- Fresno, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES (K973673) | Sunrise Medical, Inc. | 1997-11-20 |