BEUDAMED
    FDA Enforcement Class II Terminated

    Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355

    Recall: Z-0418-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0418-2021
    Event ID
    86627
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2020
    Initiation Date
    October 14, 2020
    Classification Date
    November 5, 2020
    Termination Date
    October 19, 2021
    Address
    603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States

    Description

    Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355

    Reason

    5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component

    Code Info

    Lot Number: 5626935 Expiration Date: 08/31/2023

    Distribution

    US Nationwide distribution including in the states of AL, CT, GA, FL.

    Quantity

    32 kits