BEUDAMED
    FDA Enforcement Class II Terminated

    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

    Recall: Z-2180-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2180-2012
    Event ID
    62341
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Worldwide Headquarters
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    June 15, 2012
    Classification Date
    August 9, 2012
    Termination Date
    February 10, 2016
    Address
    14 Plaza Dr, Latham, NY, 12110-2166, United States

    Description

    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

    Reason

    AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.

    Code Info

    Lot: 564325

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.

    Quantity

    7 boxes/35 units