Events

Recall of Device Recall TriState Centurion Incision & Drainage 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
    51439
  • Event Risk Class
    Class 2
  • Event Number
    Z-1321-2009
  • Event Initiated Date
    2009-01-14
  • Event Date Posted
    2009-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80296
  • 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
    Kit, surgical instrument, disposable - Product Code KDD
  • Reason
    Compromised sterility, as the package seals may be inadequate.
  • Action
    A letter titled "Urgent Product Recall Notice" was sent by Tri-State Hospital Supply Corporation to all consignees via certified mail titled dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand by sending the Accountability Information Form to the firm via fax (1-517-546-3356) or email and to hold the product for retrieval. Further questions should be addressed to Tri-State Hospital Supply Corp. at 1-517-546-5400 extension 1135.

Device

Device Recall TriState Centurion Incision & Drainage Tray
  • Model / Serial
    Lot Number: 2008111450.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including states of NC, FL, TX, NJ, IL, MA, GA and IA.
  • Product Description
    Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI; Reorder ID615.
  • 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