Events

Recall of LifePort¿, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255

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
    30048
  • Event Risk Class
    Class 2
  • Event Number
    Z-0256-05
  • Event Initiated Date
    2004-09-20
  • Event Date Posted
    2004-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35078
  • 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
    Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
  • Reason
    The product has an incorrectly sized introducer included in the kit. the kit contains a 12 french introducer instead of a 7 french introducer.
  • Action
    Consignees were notified by letter on 09/20/2004.

Device

LifePort¿, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF...
  • Model / Serial
    Catalog #LPS 7255, Lot #20474
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL, GA, LA, MD, NJ, OK, TX, VA
  • Product Description
    LifePort¿, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray ¿ is then sterilized. The primary sterile barrier is the inner sealed tray.
  • 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