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.
FDA Recall Z-0809-2013 · Posted 2013-02-13
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Recalling FirmCHENICA INC.
Recall StatusTerminated
Product CodeIOR
Date Initiated2013-01-18
Date Terminated2014-04-15
Product Quantity53
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).
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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