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U.S. Department of Health and Human Services

Class 2 Device Recall Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster)

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 Class 2 Device Recall Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster)see related information
Date Initiated by FirmJanuary 18, 2013
Date PostedFebruary 13, 2013
Recall Status1 Terminated 3 on April 15, 2014
Recall NumberZ-0809-2013
Recall Event ID 64110
510(K)NumberK111636 
Product Classification Wheelchair, mechanical - Product Code IOR
ProductChenica 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.
Code Information Serial Numbers: 36977-1210, 37194-0312, 37455-1111, 37606-0312, 36988-1210, 37220-0511, 37484-1111, 37614-0312, 36999-1210, 37234-0511, 37495-1211, 37628-0312, 37000-1210, 37273-0611, 37497-0711, 37632-0312, 37003-1210, 37305-0711, 37515-1211, 37633-0312, 37014-1210, 37307-0711, 37520-1211, 37636-0312, 37061-0211, 37333-0711, 37521-1211, 37637-0411, 37067-0111, 37348-0811, 37523-1211, 37675-0412, 37094-0211, 37374-0911, 37537-0112, 37681-0412, 37114-0211, 37393-0911, 37555-0112, 37286-0511, 37122-0211, 37394-0911, 37576-0212, 37296-0611, 37137-0311, 37440-1011, 37584-0212, 37141-0311, 37448-1011, 37594-0212, 37185-0311, 37449-1011, 37601-0312.
Recalling Firm/
Manufacturer		 CHENICA INC.
50 Enterprise Dr
Vassar MI 48768-9504
For Additional Information ContactAndrew J. Evancho
800-551-0055
Manufacturer 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).
FDA Determined
Cause 2		Labeling False and Misleading
ActionGunnell 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 in Commerce53
DistributionNationwide Distribution-including the states of Florida, Michigan, South Carolina, California, Texas, Maryland, New York, Tennessee, Virginia, Illinois, Ohio, Massachusetts, Arizona and Washington.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = IOR
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