Events

Recall of Device Recall VitalPort Vascular Access System

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
    79425
  • Event Risk Class
    Class 2
  • Event Number
    Z-1223-2018
  • Event Initiated Date
    2017-11-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162287
  • 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
    Non-coring needle provided with the cook vital-port¿ vascular assess system (vital-port) may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port. vital-port products that have been successfully placed in patients are not impacted by this recall.
  • Action
    Removal for all non-expired lots of the Cook Vital-Port Vascular Access System. Written recall communication letters will be mailed via courier to US Consignees.plan to STORE recalled product(s)? (if returned) Recalled products will be returned to global regional distribution warehouses to be quarantined in a marked receiving area of returned goods. 8.9 Provide plan for final DISPOSITION for recalled product(s)? All recalled products will be destroyed at the regional distribution warehouses. A certificate of destruction will be provided upon completion of destruction prior to the completion of the recall. Products remaining in the control of Cook will be assessed for rework to replace the non-coring needle.

Device

Device Recall VitalPort Vascular Access System
  • Model / Serial
    IPI, P-S
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.
  • Product Description
    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, || Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
  • 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