BEUDAMED
    FDA Recall Terminated

    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

    Recall: Z-2539-2017 · Initiated May 9, 2017

    Recall

    Recall Number
    Z-2539-2017
    Event Number
    77304
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 9, 2017
    Posted
    June 5, 2017
    Terminated
    January 26, 2018
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

    Reason

    Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

    Action

    Cook is initiating a voluntary recall of multiple products in the form of a correction to the product Instructions for Use. Cook Inc. has identified the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Cook distributed notices via courier on May 9, 2017. Customers were instructed to do the following: Distribution of the Cook Multi-Use Holmium Laser Fibers will not occur until the reprocessing instructions in the Instructions for Use have been corrected. Single use fibers are available. Contact your local sales representative for further information. You can continue to use your inventory of Cook Multi-Use Holmium Laser Fibers by following the attached Suggested Fiber Reprocessing Instructions. Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Implement the updated Suggested Fiber Reprocessing Instructions. 3. Return the required Acknowledgement and Receipt Form within 30 days. 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email ([email protected]). 5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at [email protected]. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Should you have any medical questions or concer

    Distribution

    Domestic: AL AR AZ CA CO FL GA HI ID IL IN KY LA MD MI MO MS NC NM NY OH OK OR PA SC TN TX UT VA WA WI Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Spain, Slovenia, South Africa, Sri Lanka, Sweden, Singapore, Taiwan, Thailand, Tunisia, United Kingdom, and Uruguay

    Quantity

    4369