Events

Recall of Device Recall POSTOP EYE 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
    76730
  • Event Risk Class
    Class 2
  • Event Number
    Z-1730-2017
  • Event Initiated Date
    2017-03-09
  • Event Date Posted
    2017-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154048
  • 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
    Dressing change tray - Product Code OXQ
  • Reason
    Centurion medical products is recalling convenience kits that contain covidien curity oval eye pads due to supplier's recall because of potential breach in sterile packaging.
  • Action
    On March 9, 2017 Centurion Medical Products recalled specific lots of medical convenience kits due to a supplier initiated recall of Covidien Curity Eye Pads. All affected customers were notified, advised to discontinue use of associated kits, and requested to confirm the status of remaining stock to Centurion.

Device

Device Recall POSTOP EYE TRAY
  • Model / Serial
    Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016100390 12/31/18 2016092190 12/31/18 2016072790 10/31/18 2016061590 4/30/18 2016031490 4/30/18 2016022390 4/30/18 2015111190 4/30/18 2015092890 4/30/18 2015083190 9/30/17 2015032390 10/31/17 2015052890 9/30/17 2015052090 9/30/17 2015050590 9/30/17
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
  • Product Description
    POST-OP EYE TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.
  • 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