BEUDAMED
    FDA Recall 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 · Initiated March 21, 2016

    Recall

    Recall Number
    Z-1702-2016
    Event Number
    73815
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    March 21, 2016
    Posted
    May 20, 2016
    Terminated
    September 18, 2017
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    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.

    Action

    On 3/21/2016, AngioDynamics sent recall notification packages (dated 3/21/2016) to the consignees via Federal Express. Consignees are instructed to follow the instructions provided on the Maquet Cardiopulmonary recall letter (dated 2/23/2016) and return the Reply Verification Tracking Form, provided in the recall notification.

    Distribution

    Nationwide Distribution.

    Quantity

    Domestic: 377 kits