Events

Recall of GENERAL PURPOSE INSTRUMENT 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-1080-2018
  • 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=162164
  • 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

GENERAL PURPOSE INSTRUMENT TRAY
  • Model / Serial
    75121 75175 71435 75455 75690 SR245  Lot codes: 2017071990 2016110990 2016040790  2017022090 2016112490 2017010390 2017082390 2015101290 2015111790 2016032290 2016051790 2016053090 2016102490 2017013190 2017032990 2017080290 2015110390 2016010490 2016012090 2016020890 2016041890 2016061390 2016090590 2016110790 2017010990 2017021390 2017032190 2015092190 2015120190 2015121490 2016022590 2016120190 2017010390 2017011090 2015093090 2015112390 2016020390 2016092290 2016091590
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    GENERAL PURPOSE INSTRUMENT 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