Events

Recall of Device Recall The Model 8540 Catheter Access Port Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc, Neurological & Spinal Division.

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
    29663
  • Event Risk Class
    Class 2
  • Event Number
    Z-1384-04
  • Event Initiated Date
    2004-07-23
  • Event Date Posted
    2004-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34304
  • 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
    Pump, Infusion, Implanted, Programmable - Product Code LKK
  • Reason
    The sterile tray label for the model 8540 catheter access port kit may be incorrectly labeled with a model 8551 refill kit label. the outer box of the affected model 8540 catheter access port kit is labeled correctly and the component parts within the sterile tray are the correct components for a model 8540 catheter access port kit. the issue is limited to one lot of product: cs0293.
  • Action
    The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of manufactured product: CS0293.

Device

Device Recall The Model 8540 Catheter Access Port Kit
  • Model / Serial
    CS0293
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US and one customer in New Zealand.
  • Product Description
    The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK.
  • Manufacturer
    Medtronic Inc, Neurological & Spinal Division

Manufacturer

Medtronic Inc, Neurological & Spinal Division
  • Manufacturer Address
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA