Events

Recall of Device Recall Deltec Ventra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deltec, 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
    26715
  • Event Risk Class
    Class 2
  • Event Number
    Z-1066-03
  • Event Initiated Date
    2003-07-08
  • Event Date Posted
    2003-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28246
  • 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
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
  • Reason
    Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
  • Action
    A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.

Device

Device Recall Deltec Ventra
  • Model / Serial
    Lot numbers M20689, 90299, 85047
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
  • Product Description
    Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector Segments and Single-Lumen Catheters, Reorder Number 21-0105
  • Manufacturer
    Deltec, Inc

Manufacturer

Deltec, Inc
  • Manufacturer Address
    Deltec, Inc, 1265 Grey Fox Road, St Paul MN 55112
  • Source
    USFDA