BEUDAMED
    FDA Recall 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 · Initiated September 22, 2017

    Recall

    Recall Number
    Z-0742-2018
    Event Number
    79193
    Firm
    Angiodynamics, Inc.
    FEI Number
    1319211
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2017
    Posted
    February 13, 2018
    Terminated
    September 19, 2018
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619

    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.

    Action

    Consignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form. For further questions, please call (518) 795-1676.

    Distribution

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

    Quantity

    28