Events

Recall of Device Recall Introducer catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson Infusion Therapy.

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
    28397
  • Event Risk Class
    Class 2
  • Event Number
    Z-0587-04
  • Event Initiated Date
    2004-02-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31764
  • 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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
  • Reason
    Splittable catheter introducer may not fully split or may separate non-uniformly.
  • Action
    On 02/03/2004, all consignees were notified by telephone and letter.

Device

Device Recall Introducer catheter
  • Model / Serial
    Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
  • Product Description
    BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
  • Manufacturer
    Becton Dickinson Infusion Therapy

Manufacturer

Becton Dickinson Infusion Therapy
  • Manufacturer Address
    Becton Dickinson Infusion Therapy, 9450 South State Street, Sandy UT 84070
  • Source
    USFDA