Events

Recall of Centurion

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Centurion Medical Products.

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
    55305
  • Event Risk Class
    Class 2
  • Event Number
    Z-1595-2010
  • Event Initiated Date
    2010-04-09
  • Event Date Posted
    2010-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90519
  • 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
    general surgery kit - Product Code GEI
  • Reason
    The firm is conducting a sub recall of kits containing conmed goldline rocker switch pencils. the pencils activation switch may remain in the "on" position after the switch has been depressed with excessive force, thereby continuously activating the pencil.
  • Action
    Centurion sent out an "Urgent Product Recall Notice" to one customer on 4/9/2010. The customer was instructed to discontinue use of the product. The customer was also instructed to return any instock product .

Device

Centurion
  • Model / Serial
    2009100590, 2009110990, 2009121490, 2010011190 and 2010031590.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX
  • Product Description
    Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
  • Manufacturer
    Centurion Medical Products

Manufacturer

Centurion Medical Products
  • Manufacturer Address
    Centurion Medical Products, 301 Catrell Dr, Howell MI 48843-1703
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA