Events

Recall of Device Recall Centurion Port Access Dressing Change Tray

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
    55885
  • Event Risk Class
    Class 2
  • Event Number
    Z-1936-2010
  • Event Initiated Date
    2010-03-16
  • Event Date Posted
    2010-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92155
  • 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
    Start/Stop Dialysis Tray - Product Code FKG
  • Reason
    The 3m micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.
  • Action
    The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.

Device

Device Recall Centurion Port Access Dressing Change Tray
  • Model / Serial
    905058, 902188, 902118, 2008101390, 2008110390, 2008120190, 2009011990, 2009012690, 2009021690, 2009040690, 2009051190, 2009060190, 2009062990, 2009072790, 2009101290, 2009110290 and 2010011890.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR and OH.
  • Product Description
    Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape, Single Use Rolls, Port Access Dressing Change Tray, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
  • 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