Events

Recall of Centurion Healthcare Products Arthrogram 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
    46155
  • Event Risk Class
    Class 3
  • Event Number
    Z-0730-2008
  • Event Initiated Date
    2007-10-26
  • Event Date Posted
    2008-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66907
  • 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
    Surgical Disposable Instrument - Product Code KDC
  • Reason
    Incorrect needle size - some of the kits contain a 1 inch 21g needle instead of the 1-1/2 inch 21 needle specified on the kit label.
  • Action
    An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product.

Device

Centurion Healthcare Products Arthrogram Tray
  • Model / Serial
    Lot Number: 907097.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including states of Massachusetts and Washington.
  • Product Description
    Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size.
  • 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