Events

Recall of Device Recall Thoracentesis/Paracentesis Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 2200 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
    76620
  • Event Risk Class
    Class 2
  • Event Number
    Z-1426-2018
  • Event Initiated Date
    2017-02-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163196
  • 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
    Tray, surgical, needle - Product Code FSH
  • Reason
    The integrity of the sterile packaging is potentially compromised.
  • Action
    On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.

Device

Device Recall Thoracentesis/Paracentesis Kit
  • Model / Serial
    Product Code: TPK1001 / LOT 0000837811, 0000842215, 0000840336, 0000851185
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
  • Product Description
    Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Manufacturer Address
    Carefusion 2200 Inc, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA