Events

Recall of INCISION & DRAINAGE TRAY or KIT

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-1088-2018
  • 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=162173
  • 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

INCISION & DRAINAGE TRAY or KIT
  • Model / Serial
    ID1090 ID1485 ID1525 ID1595 ID510 ID525 ID580 ID600 ID800 ID875 ID975  Lot codes: 2015102190 2016010790 2016020890 2016022390 2016061090 2016071990 2016101290 2016110390 2017011990 2016121690 2017022390 2017052690 2015101490 2016060690 2016070890 2016102490 2017032190 2017052390 2015091790 2015111990 2015112590 2016070890 2016072790 2016082390 2017020290 2017032890 2017052690 2017030390 2015092490 2015121490 2016010690 2016033190 2016042790 2016052490 2016061390 2016102790 2016112490 2017042890 2017063090 2017071990 2015100890 2017072890 2017040690 2016092290 2016031790 2016012190 2017030290 2016021890 2016060890 2016070790 2016080590 2016111190 2017010990 2017051190 2015110590 2015103090 2016071490 2015121590 2016031590 2016042090 2016051890 2016052590 2016062190 2016110190 2017010390 2017020890 2017040490 2017060890 2017062890 2017082290 2016112290 2016042790 2017060890 2017070790 2017082490 2015101590 2016022590 2016072890 2016090290 2017011190 2017040690 2017061690 2017081190 2017011690 2015092490 2015100890 2015111990 2016040690 2016060890 2016071890 2017013090 2016030790 2016031590 2016080190 2017010390 2017050490 2016072090 2015081190 2015102790 2016010490 2016022490 2016031190 2016060690 2016082990 2016111790 2017011790 2017032890 2017060790 2017071290 2016011590 2016062390 2016062890
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationally
  • Product Description
    INCISION & DRAINAGE TRAY or KIT
  • 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