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U.S. Department of Health and Human Services

Class 2 Device Recall Care Cliner

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  Class 2 Device Recall Care Cliner see related information
Date Initiated by Firm February 06, 2012
Date Posted April 25, 2012
Recall Status1 Terminated 3 on July 27, 2012
Recall Number Z-1458-2012
Recall Event ID 61457
Product Classification Chair, with casters - Product Code INM
Product CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550/6570 (w/ NYLON CASTERS)***Winco ISO 9001-2008 Certified***All of our best features, plus the added versatility of drop arms***Leave it to Winco to combine the best clinical chair features in the industry with the convenience of dual drop-arms! Our drop-arm care cliners make assisting your patients easier. Our side-panels lift, making clean-ups quick and easy.***KEY FEATURES***Standard head-rest cover***Padded drop-down armrests***Dual fold down side-tables***Easy-to-clean side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***".

Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***"

The Care Cliner is 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 6550, 6570.
Recalling Firm/
Manufacturer		 Winco Mfg., LLC
5516 SW 1st Ln
Ocala FL 34474-9307
For Additional Information Contact Christine Tarro
352-854-2929
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 in Commerce 1,311 Casters (437 Chairs)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.
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.
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