Recall Z-0777-2013 ยท INM Chair, With Casters
Winco Mfg., LLC
PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
| Date | Feb 4, 2013 (initiated Sep 24, 2012) |
| Status | Terminated |
| Reason | The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. |
| Root cause | Component design/selection |
| Action | Winco sent a Chair Field Correction Notification dated September 24, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to forward the "Field Correction Form - REPAIR" form back to Winco and the firm would send a Winco Representative to the consignees' facility to correct the chairs in the field. Customers with questions were instructed to contact Winco at 800-237-3377 or email customerservice@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 110. |
| Quantity | 95 units (all models) |
| Distribution | Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.