BEUDAMED
    FDA Recall Terminated

    GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.

    Recall: Z-2029-2012 · Initiated April 9, 2012

    Recall

    Recall Number
    Z-2029-2012
    Event Number
    62408
    Firm
    Gulf Fiberoptics, Inc.
    FEI Number
    3003768921
    Product Code
    FST
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 9, 2012
    Posted
    July 18, 2012
    Terminated
    March 7, 2013
    Address
    448 Commerce Blvd, Oldsmar, FL, 34677-2808

    Description

    GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.

    Reason

    The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.

    Action

    The firm, Gulf Fiberoptics, Inc., sent an "RECALL NOTIFICATION-PLEASE DO NOT DISCARD" letter dated April 09, 2012 to its customer via (traceable letter & email). A notification was put on the firm's website. The letter described the product, problem and actions to be taken. The distributors were instructed to determine the status of the product; remove existing product from service immediately and return to their company in a timely manner; send all returned GMF-RC65 cables to Gulf Fiberoptics; forward copies of the recall letters to their customers, ultimately the end user, and complete and return the attached Recall Worksheet Form for each GMF-RC65 cables regardless of its status via fax to: +1 813.855.6627; email to: [email protected] or mail to : Gulf Fiberoptics, 448 Commerce Blvd, Oldsmar, FL 34677. The customers were instructed to remove the cables from service immediately, if they think they may have one of the listed cables; contact customer service at +1 813.855.6618 for serial number verification and for instructions to return this cable to Gulf Fiberoptics. If you have any questions regarding this voluntary recall, please contact your Customer Service representative at: +1813.855.6618 or by email at: [email protected].

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, FL, MI, NC, NJ, NY, OH, PA, TN, TX and WI and country of: South Africa.

    Quantity

    169 units