Events

Recall of Device Recall AngioVac Circuit Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics Inc. (Navilyst Medical Inc.).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73815
  • Event Risk Class
    Class 2
  • Event Number
    Z-1702-2016
  • Event Initiated Date
    2016-03-21
  • Event Date Posted
    2016-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145039
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • 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.

Device

Device Recall AngioVac Circuit Pack
  • Model / Serial
    Lot Numbers: 4876386, 4889699, 4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product 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.
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • Manufacturer Address
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA