Recall Z-0809-2013 ยท IOR Wheelchair, Mechanical
CHENICA INC.
Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
| Date | Feb 13, 2013 (initiated Jan 18, 2013) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111636 | REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM Gunnell, Inc., Apr 3, 2012 |