BEUDAMED
    FDA Enforcement Class II Terminated

    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

    Recall: Z-0619-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0619-2019
    Event ID
    81615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    November 8, 2018
    Classification Date
    December 17, 2018
    Termination Date
    October 13, 2020
    Address
    600 N FIELD DRIVE, LAKE FOREST, IL, 60045, United States

    Description

    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

    Reason

    There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.

    Code Info

    UDI 108877870074, All codes

    Distribution

    US distribution and Internationally to Canada.

    Quantity

    31,050 units