BEUDAMED
    FDA Recall Terminated

    Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

    Recall: Z-1928-2020 · Initiated October 7, 2019

    Recall

    Recall Number
    Z-1928-2020
    Event Number
    85409
    Firm
    Edwards Lifesciences, LLC
    FEI Number
    2015691
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 7, 2019
    Posted
    May 8, 2020
    Terminated
    April 27, 2021
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

    Reason

    Intermittent communication due to inconsistent crimping of connectors onto cables.

    Action

    On xx/xx/2019, and URGENT MEDICAL DEVICE RECALL-ACTION REQUIRED, letter was sent to customers by FedEx. Customers are instructed to acknowledge this 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 recalling firm.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.

    Quantity

    35