BEUDAMED
    FDA Enforcement Class II Terminated

    AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

    Recall: Z-1702-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1702-2016
    Event ID
    73815
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    March 21, 2016
    Classification Date
    May 20, 2016
    Termination Date
    September 18, 2017
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

    Reason

    Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

    Code Info

    Lot Numbers: 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714.

    Distribution

    Nationwide Distribution.

    Quantity

    Domestic: 377 kits