Events

Recall of Device Recall CENTURION PORT ACCESS TRAY

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Centurion Medical Products 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
    58346
  • Event Risk Class
    Class 2
  • Event Number
    Z-2338-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99120
  • 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, i.V. Start - Product Code MCY
  • Reason
    This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.
  • Action
    Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.

Device

Device Recall CENTURION PORT ACCESS TRAY
  • Model / Serial
    BATCHES 2009122950 AND 2010081950. .
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Material DT5035, PORT ACCESS TRAY, CENTURION PORT ACCESS TRAY, REORDER DT5035, STERILE..., CENTURION MEDICAL PRODUCTS CORP. HOWELL MI 48843 USA 800.248.4058 www.centurionmp.com || FACILITATES DRESSING CHANGE
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Manufacturer Address
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA