BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1458-2012 · Initiated February 6, 2012

    Recall

    Recall Number
    Z-1458-2012
    Event Number
    61457
    Firm
    Winco Mfg., LLC
    FEI Number
    1027229
    Product Code
    INM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2012
    Posted
    April 25, 2012
    Terminated
    July 27, 2012
    Address
    5516 SW 1st Ln, Ocala, FL, 34474-9307

    Description

    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.

    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

    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.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.

    Quantity

    1,311 Casters (437 Chairs)