Events

Recall of Device Recall NAMIC Fluid Delivery Set

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
    76347
  • Event Risk Class
    Class 2
  • Event Number
    Z-1853-2017
  • Event Initiated Date
    2017-01-13
  • Event Date Posted
    2017-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152938
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    The product has the potential to be non-sterile as it was not packaged in accordance to specification.
  • Action
    On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification.

Device

Device Recall NAMIC Fluid Delivery Set

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