Events

Recall of Device Recall Port/PICC Access Kit

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
    57661
  • Event Risk Class
    Class 2
  • Event Number
    Z-1018-2011
  • Event Initiated Date
    2010-12-06
  • Event Date Posted
    2011-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96985
  • 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
    Kit, i.V. Start - Product Code LRS
  • Reason
    The firm is conducting a recall of kits that contain the monoject prefill advanced flush syringes containing heparin. the syringes are under recall by their manufacturer coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium usp contained low level of over-sulfated chondroitin sulfate (oscs)".
  • Action
    The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: sdfeedback@covidien.com. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: sdfeedback@covidien.com or fax: 302-822-6009.

Device

Device Recall Port/PICC Access Kit
  • Model / Serial
    2010032280, 2010051080 and 2009122880.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.
  • Product Description
    Port/PICC Access Kit, Reorder CV13240, Sterile, Centurion Medical Products Corp. Williamston, MI || Intended use: Vascular access port kit
  • 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