BEUDAMED
    FDA Recall Terminated

    Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

    Recall: Z-1870-2017 · Initiated March 7, 2017

    Recall

    Recall Number
    Z-1870-2017
    Event Number
    76927
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    FCS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 7, 2017
    Posted
    April 19, 2017
    Terminated
    October 16, 2018
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

    Reason

    Product may overheat, melt, and burn patient.

    Action

    On 3/7/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Action To Be Taken: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email to ([email protected]). 4. Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days. 5. Report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern time), or by email via [email protected]. This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

    Distribution

    The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jersey, Kuwait, Mexico, Morocco, New Zealand, Norway, Panama, Paraguay, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Trinidad and Tobago, United Arab Emirates and the United Kingdom.

    Quantity

    19756