Events

Recall of Device Recall NAMIC

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
    79558
  • Event Risk Class
    Class 2
  • Event Number
    Z-1390-2018
  • Event Initiated Date
    2018-01-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162640
  • 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
    Angiography/angioplasty kit - Product Code OEQ
  • Reason
    Namic fluid management convenience kits contains a fluid delivery set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
  • Action
    Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form.

Device

Device Recall NAMIC
  • Model / Serial
    Lot Numbers: 5284422 5286610 5283649 5290525 5286542
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
  • Product Description
    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management || and/or Invasive Pressure Monitoring systems.
  • 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