Recall Z-1457-2012 ยท INM Chair, With Casters
Winco Mfg., LLC
CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON CASTERS)***Winco***ISO 9001-2008 Certified***Outstanding Value and Quality in Our Standard Care Cliner***Lower price does not mean lower quality when you buy a Winco Care Clinger. Our standard Care Cliner comes with all the superior features you might find on higher-priced clinical chairs.***KEY F
| Date | Apr 25, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this |
| Root cause | Device Design |
| Action | Winco Mfg. sent an "URGENT DEVICE RECALL" letter dated February 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete the Caster Recall Replacement Form and return it to the firm's Customer Service Department via fax to 352-854-9544. Contact the Customer Service Department at 800 237-3377 for questions regarding this notice. |
| Quantity | 1,080 Casters (360 chairs) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.