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U.S. Department of Health and Human Services

Class 2 Device Recall PREMIER LIFECARE RECLINER 5400

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  Class 2 Device Recall PREMIER LIFECARE RECLINER 5400 see related information
Date Initiated by Firm September 24, 2012
Date Posted February 04, 2013
Recall Status1 Terminated 3 on May 23, 2013
Recall Number Z-0777-2013
Recall Event ID 63651
Product Classification Chair, with casters - Product Code INM
A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Code Information Model 5400.  Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.  
Recalling Firm/
Winco Mfg., LLC
5516 SW 1st Ln
Ocala FL 34474-9307
For Additional Information Contact Steven Goodson
352-854-2929 Ext. 110
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 in Commerce 95 units (all models)
Distribution Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
Total Product Life Cycle TPLC 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.