BEUDAMED
    FDA Recall Open, Classified

    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

    Recall: Z-0720-2023 · Initiated November 7, 2022

    Recall

    Recall Number
    Z-0720-2023
    Event Number
    91138
    Firm
    Cordis US Corp
    FEI Number
    1016427
    Product Code
    DQO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2022
    Posted
    December 16, 2022
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

    Reason

    There is a potential for separation at the male connector.

    Action

    Cordis notified consignees on approximately 11/07/2022 via letter titled "Urgent MEDICAL DEVICE RECALL" sent to the Materials Director and Risk Manager. The letter instructed consignees to identify and segregate any affected product on hand, complete and return the Acknowledgement Form by email: [email protected], and return all affected product. Additionally, customers were instructed to share the letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units. OUS consignee notification will be conducted by Cordis affiliates in the affected countries / regions. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through Friday from 9:00 AM to 5:00 PM EDT. For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00 AM to 8:00 PM EDT. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: [email protected].

    Distribution

    Nationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.

    Quantity

    16,950 units (2,915 US and 14,000 OUS)