Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Rec
FDA device recall Z-0809-2013 · posted 2013-02-13 · Terminated
Recall details
- Recalling firm
- CHENICA INC.
- Reason for recall
- The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).
- Action taken
- Gunnell Inc. sent a "RE: URGENT MEDICAL DEVICE CORRECTION/RECALL" letter dated January 18, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm 1-800-551-0055 for questions relating to this letter.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 53
- Distribution
- Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.
- Date initiated
- 2013-01-18
- Date posted
- 2013-02-13
- Date terminated
- 2014-04-15
- Location
- Vassar, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM (K111636) | Gunnell, Inc. | 2012-04-03 |