BEUDAMED
    FDA Enforcement Class II Terminated

    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

    Recall: Z-2051-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2051-2021
    Event ID
    88074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    June 15, 2021
    Classification Date
    July 9, 2021
    Termination Date
    January 12, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

    Reason

    There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

    Code Info

    Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.

    Distribution

    United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.

    Quantity

    4,752 units