Events

Recall of Device Recall AngioDynamics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Enpath 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
    28419
  • Event Risk Class
    Class 2
  • Event Number
    Z-0711-04
  • Event Initiated Date
    2004-02-26
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31808
  • 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
    Needle, Aspiration And Injection, Disposable - Product Code GAA
  • Reason
    The product is labeled as sterile product but had not been sterilized.
  • Action
    The only direct consignee, to whom the product was shipped, was notified of the recall by telephone and fax on February 26, 2004. The consignee was requested to the return the product and to sub-recall the product from their customers.

Device

Device Recall AngioDynamics
  • Model / Serial
    Lot W24005, Use By 2005-03
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    All of the product was shipped to a distributor in New York.
  • Product Description
    AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
  • Manufacturer
    Enpath Medical, Inc.

Manufacturer

Enpath Medical, Inc.
  • Manufacturer Address
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA