BEUDAMED
    FDA Enforcement Class II Terminated

    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

    Recall: Z-0742-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0742-2018
    Event ID
    79193
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    September 22, 2017
    Classification Date
    February 27, 2018
    Termination Date
    September 19, 2018
    Address
    603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States

    Description

    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

    Reason

    Product was placed into distribution prior to completion of all required post sterilization release activities.

    Code Info

    Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20

    Distribution

    US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.

    Quantity

    28