BEUDAMED
    FDA Enforcement Class II Terminated

    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

    Recall: Z-1016-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-1016-2022
    Event ID
    89882
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Freudenberg Medical, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 4, 2022
    Initiation Date
    February 21, 2022
    Classification Date
    April 28, 2022
    Termination Date
    April 18, 2024
    Address
    2301 Centennial Blvd, Jeffersonville, IN, 47130-8975, United States

    Description

    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

    Reason

    Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

    Code Info

    Lot Numbers: PD01, PD00013140 UDI: 00850004312001

    Distribution

    US distribution: GA, OH Foreign distribution: Netherlands

    Quantity

    13 units (US)