BEUDAMED
    FDA Recall Terminated

    The Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.

    Recall: Z-0847-2011 · Initiated February 23, 2010

    Recall

    Recall Number
    Z-0847-2011
    Event Number
    56829
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 23, 2010
    Posted
    January 4, 2011
    Terminated
    March 22, 2012
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    The Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.

    Reason

    ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due to there is a possibility that the Vid

    Action

    ConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form. Customers were asked to document delivery of replacement plugs on the Sales Rep Reply Form and mail back or return by fax to 1-888-370-3062. For questions regarding this recall call the Customer Service Department at 1-888-292-0100 or e-mail [email protected].

    Distribution

    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela.

    Quantity

    77 ea