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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 5400see related information
Date Initiated by FirmOctober 17, 2011
Date PostedFebruary 26, 2012
Recall Status1 Terminated 3 on May 04, 2012
Recall NumberZ-1105-2012
Recall Event ID 61049
Product Classification Chair, with casters - Product Code INM
ProductPremier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 540***Serial No. 540-...***" Press on type label: "***Model No. 557-...***Serial No.***". Long-term multi-positional recliner.
Code Information Model 5400
Recalling Firm/
Manufacturer		 Winco Mfg., LLC
5516 SW 1st Ln
Ocala FL 34474-9307
For Additional Information ContactDennis Chandler
352-854-2929
Manufacturer Reason
for Recall		On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4, 2011 and October 12, 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature.
FDA Determined
Cause 2		Device Design
ActionWinco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.
Quantity in Commerce54 chairs
DistributionWorldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, KS, MA, MI, MO, MS, NC, NM, NY, OK, PA, SC, SD, TN, TX, VA, WI, and the country of Canada.
Total Product Life CycleTPLC 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.
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