Events

Recall of Polysulfone Petite Vital Port

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Vascular 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
    48642
  • Event Risk Class
    Class 2
  • Event Number
    Z-2191-2008
  • Event Initiated Date
    2008-04-24
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71785
  • 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
    Mislabeled - wrong size catheter was packaged in the box.
  • Action
    The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.

Device

Polysulfone Petite Vital Port
  • Model / Serial
    Catalog number IP-S6118. Lot number N73153
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were shipped to distributors in Japan and Brazil.
  • Product Description
    Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
  • Manufacturer
    Cook Vascular Inc.

Manufacturer

Cook Vascular Inc.
  • Manufacturer Address
    Cook Vascular Inc., 1186 Montgomery Ln, Vandergrift PA 15690-6065
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA