Events

Recall of Device Recall Circle C

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Horizon Medical Products Inc.

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
    29253
  • Event Risk Class
    Class 2
  • Event Number
    Z-1030-04
  • Event Initiated Date
    2004-05-28
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33428
  • 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
    Accessories, Blood Circuit, Hemodialysis - Product Code KOC
  • Reason
    The products have a potential defective seal that closes the product's outer pouch. the surface of the inner tray may no longer be sterile.
  • Action
    Consignees were notified via letter on 5/28/2004.

Device

Device Recall Circle C
  • Model / Serial
    Catalog # DLC800-TEC, Lot Numbers 3538781, 356779 & 342251.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX & VA.
  • Product Description
    Circle C¿ Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.
  • Manufacturer
    Horizon Medical Products Inc

Manufacturer

Horizon Medical Products Inc
  • Manufacturer Address
    Horizon Medical Products Inc, 1 Horizon Way, Manchester GA 31816-1749
  • Source
    USFDA