Events

Recall of CIRCUMCISION 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
    79329
  • Event Risk Class
    Class 2
  • Event Number
    Z-1082-2018
  • Event Initiated Date
    2017-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162166
  • 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
    Tray, surgical - Product Code LRP
  • Reason
    Convenience kit contains a pvp prep pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
  • Action
    On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.

Device

CIRCUMCISION TRAY
  • Model / Serial
    CIT6020 CIT6120  Lot codes: 2015081790 2015112090 2016011190 2016022390 2016031690 2016042690 2016061590 2016080890 2016090690 2016100790 2017010990 2017020990 2017040490 2017051590 2017061690 2015111390 2016012190 2016022390 2016033190 2016060690 2016071890 2016092290 2016111590 2017020990 2017030790 2017041390 2017051590
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    CIRCUMCISION TRAY
  • 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