Events

Recall of Device Recall Pump Fill 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
    54623
  • Event Risk Class
    Class 1
  • Event Number
    Z-1140-2010
  • Event Initiated Date
    2010-02-01
  • Event Date Posted
    2010-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88803
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    A supplier notified this firm of a recall of their huber needles because the needles that are labeled as non-coring could core 60-72% of the time. centurion is doing a sub recall of their kits that contain the referenced needles.
  • Action
    An "URGENT MEDICAL DEVICE WITHDRAWAL" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch. The customers were also instructed to check the lot numbers of products in inventory to determine if they have products affected by this withdrawal and complete and return the enclosed Customer Response Form by fax or email. Direct all inquiries to: EXEL International Customer Service 727-827-1922 ext. 0 Monday through Friday 9am-5pm EST or E-mail info@exelint.com

Device

Device Recall Pump Fill Kit
  • Model / Serial
    911127, 901218, 908258, 2008091590, 2008111790, 2009011290, 2009062290, 2009090790, 2009100590 and 2009112390.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA only
  • Product Description
    Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY || The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill 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