Events

Recall of Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.

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

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
    31323
  • Event Risk Class
    Class 3
  • Event Number
    Z-0696-05
  • Event Initiated Date
    2005-03-08
  • Event Date Posted
    2005-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37665
  • 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
    Introducer, Syringe Needle - Product Code KZH
  • Reason
    Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
  • Action
    Consignees were notified via recall letter dated March 8, 2005 and asked to retun any unused product.

Device

Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.
  • Model / Serial
    Lots 11014, 12134 and 01105.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Alabama, Kentucky, Michigan, Mississippi, Missouri, North Carolina and South Carolina.
  • Product Description
    Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.
  • Manufacturer
    Tri-State Hospital Supply Corp

Manufacturer

Tri-State Hospital Supply Corp
  • Manufacturer Address
    Tri-State Hospital Supply Corp, 301 Catrell Dr, Howell MI 48843-1703
  • Source
    USFDA