BEUDAMED
    FDA Enforcement Class II Ongoing

    Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

    Recall: Z-1684-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1684-2022
    Event ID
    90725
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Saranas, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    August 10, 2022
    Classification Date
    September 7, 2022
    Address
    2450 Holcombe Blvd Ste X, N/A, Houston, TX, 77021-2039, United States

    Description

    Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

    Reason

    Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.

    Code Info

    UDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611

    Distribution

    US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.

    Quantity

    953