Events

Recall of FibriJet Endoscopic Catheter Introducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Micromedics, 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
    75890
  • Event Risk Class
    Class 2
  • Event Number
    Z-1817-2017
  • Event Initiated Date
    2016-10-20
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151600
  • 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
    Accessories, catheter - Product Code KGZ
  • Reason
    The sterile packaging may contain small channels in the seal of the pouch, if the channels are present, the package integrity may be compromised which may affect sterility assurance.
  • Action
    A Medical Device Recall Letter was sent to customers beginning 10/20/2016 via Federal Express in the US and via UPS ground in Israel. The letter identified the affected device and lot number, issue, asked for product to be discontinued from use, quarantine and notify Nordson Medical, via a response form. Response form can be faxed back at 888-504-0606, email to sharon.lynch@nordsonmedical.com or mailed to Nordson Medical, 1270 Eagan Industrial Road, Suite 120, St. Paul, MN 55121.

Device

FibriJet Endoscopic Catheter Introducer
  • Model / Serial
    Lot Number: 163010 Expiration date: June 2021
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
  • Product Description
    Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
  • Manufacturer
    Micromedics, Inc.

Manufacturer

Micromedics, Inc.
  • Manufacturer Address
    Micromedics, Inc., 1270 Eagan Industrial Rd Ste 120, Saint Paul MN 55121-1385
  • Manufacturer Parent Company (2017)
    Nordson Corporation
  • Source
    USFDA