ClearanceBrief
Recall Z-2391-2015 ยท INN Chair, Adjustable, Mechanical

Winco Mfg., LLC

Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)

DateAug 14, 2015 (initiated Apr 2, 2015)
StatusTerminated
ReasonShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Root causeNonconforming Material/Component
ActionWinco sent a field correction letter dated April 2, 2015, to all affected customers The letter identified the product, the problem, and the action to be taken by the customer. Winco instructed customers that they will replace the recliners at no charge to the customer. Winco will provide detailed instructions for the replacement of the seats by their facility staff. Winco will extend the remaining warranty on the entire chair for a period of 6 months as compensation. If product was further distributed customers were instructed to notify those customers of the field correction. Customers
Quantity1 chair
DistributionNationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.