BEUDAMED
    FDA Recall Terminated

    ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500

    Recall: Z-2458-2008 · Initiated October 31, 2007

    Recall

    Recall Number
    Z-2458-2008
    Event Number
    48195
    Firm
    Conmed Linvatec Endoscopy Division
    FEI Number
    1000125338
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 31, 2007
    Posted
    September 21, 2008
    Terminated
    September 22, 2008
    Address
    7416 Hollister Ave, Goleta, CA, 93117-2583

    Description

    ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500

    Reason

    The recall was initiated because ConMed Linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base of the VP8500 Video Cart. The potential for the wheel caster or casters to fall out of the base of the cart may result in a potential tip hazard.

    Action

    The recall was initiated by the firm sending the recall information packet via UPS overnight delivery to the Distribution and Sales Force in May 2008. The packet included: 1. Recall Notification and reply form for each consignee. 2. Instructions on the procedure to conduct the recall of the VP8500. 3. A list of affected consignees in their territory. The Recall Notification informed the customers of the potential for the wheel caster(s) to fall out of the base of the cart which may result in a potential tip hazard. The customers were instructed to discontinue the use of the VP8500 Video Cart immediately if the wheel caster(s) show any signs of being loose and to complete the recall reply form. Upon receipt of notification, distributors are supposed to : 1. Visit the affected accounts and provide them with a copy of the Recall Notification to inform them of the recall and the Recall Acknowledgment Reply Form which is to be mailed or faxed back to the firm. 2. Schedule the delivery and installation of refurbished carts to replace the recalled cart(s) by contacting Jill Cover, ConMed Linvatec Endoscopy Division at (888) 292-0100, ext. 8157 or e-mail [email protected] to arrange for replacement. 3. Move medical devices, etc. from the recalled cart(s) and set up the refurbished cart(s) with the required equipment at the account's location. (ProMEDICA will arrange for shipping of the recalled cart(s) back to ProMEDICA.)

    Distribution

    Worldwide Distribution including states of: AK, AZ, CA, FL, GA, IL, IN, KS, MD, NC, NY, OH, and PA and country of Canada.

    Quantity

    45 Units Worlwide (42 in US)