Recall Z-2397-2015
Winco Mfg., LLC · initiated April 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Codes / lots: Model Number: 6570, Serial Numbers: 657A102238, 658A102236 and 657A102237
Reason for recall
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
FDA-determined cause: Nonconforming Material/Component
Action taken
Winco 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 were asked to complete and return the enclosed field correction response form as soon as possible. Customers with questions should contact Customer Care Monday-Friday 8:30 AM-5:00 PM EST at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929.
Details
- Recall number
- Z-2397-2015
- Initiated
- April 2, 2015
- Posted by FDA
- August 14, 2015
- Terminated
- December 14, 2016
- Product code
- INN – Chair, Adjustable, Mechanical
- Quantity
- 3 chairs
- Distribution
- Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
- Recalling firm
- Winco Mfg., LLC, Ocala, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2391-2015 Class II | Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2392-2015 Class II | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2393-2015 Class II | Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2394-2015 Class II | Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2395-2015 Class II | Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2396-2015 Class II | Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2398-2015 Class II | Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2399-2015 Class II | Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2400-2015 Class II | Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2401-2015 Class II | Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2402-2015 Class II | Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2403-2015 Class II | Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |