BEUDAMED
    FDA Recall Terminated

    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

    Recall: Z-2007-2020 · Initiated March 27, 2020

    Recall

    Recall Number
    Z-2007-2020
    Event Number
    85483
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DQE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 27, 2020
    Posted
    July 10, 2020
    Terminated
    April 27, 2021
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

    Reason

    Sterile catheter kit packaging compromised.

    Action

    Recall is to the customer level. URGENT MEDICAL DEVICE RECALL- ACTION REQUIRED letter, via FedEx, along with an acknowledgment form will be sent to all customers possessing any of the affected units. Letters will be sent overnight via FedEx. Customers will be instructed to acknowledge the notification, contact the firm at the contact information in the communication to obtain a Returned Goods Authorization (RGA) number, and to return all product to the recalling firm.

    Distribution

    US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

    Quantity

    597 units