Events

Recall of TriState Centurion Venous Access Port Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tri-State Hospital Supply Corporation.

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
    52130
  • Event Risk Class
    Class 2
  • Event Number
    Z-1571-2009
  • Event Initiated Date
    2008-04-08
  • Event Date Posted
    2009-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82164
  • 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
    Venous Access Port Kits - Product Code OKE
  • Reason
    The kits contain monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
  • Action
    Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.

Device

TriState Centurion Venous Access Port Kits
  • Model / Serial
    Kit lots 802188 and 802198. Heparin flush lot 7113064.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Indiana, Mississippi, Ohio and Tennessee.
  • Product Description
    Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.
  • Manufacturer
    Tri-State Hospital Supply Corporation

Manufacturer

Tri-State Hospital Supply Corporation
  • Manufacturer Address
    Tri-State Hospital Supply Corporation, 301 Catrell Drive, Howell MI 48843
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA