BEUDAMED
    FDA Recall 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 · Initiated November 8, 2018

    Recall

    Recall Number
    Z-0619-2019
    Event Number
    81615
    Firm
    ICU Medical Inc
    FEI Number
    3013319212
    Product Code
    MRZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 8, 2018
    Terminated
    October 13, 2020
    Address
    600 N FIELD DRIVE, LAKE FOREST, IL, 60045

    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.

    Action

    On 11/08/18, Stericycle, Inc. sent a "URGENT MEDICAL DEVICE CORECTION" letter to its consignees. The letter described the product, problem and actions to be taken via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. For further inquiries, please contact ICU US Field Action Manager at 224-706-2487 or [email protected].

    Distribution

    US distribution and Internationally to Canada.

    Quantity

    31,050 units