Events

Recall of Device Recall TriState Centurion Port Access Tray

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
    50867
  • Event Risk Class
    Class 1
  • Event Number
    Z-1166-2009
  • Event Initiated Date
    2009-01-14
  • Event Date Posted
    2009-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77546
  • 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
    Procedure Tray - Product Code LRS
  • Reason
    Lack of assurance of sterility, as the package seals may be inadequate.
  • Action
    Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.

Device

Device Recall TriState Centurion Port Access Tray

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