Events

Recall of CVP CATHETER 3-LUMEN EXPANDED KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ABBOTT LABORATORIES HOSPITAL PRODUCTS DIV..

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
    17296
  • Event Risk Class
    II
  • Event Initiated Date
    2004-03-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    J tip guidewire in the central venous catheter kits would not thread through the 18g thin wall needle preventing insertion of the kit's guidewire.

Device

CVP CATHETER 3-LUMEN EXPANDED KIT
  • Model / Serial
    Model Catalog: (Lot serial: 02069SN); Model Catalog: (Lot serial: 07246SN); Model Catalog: (Lot serial: 94190SN 95227SN 04072SN)
  • Product Description
    CENTRAL VENOUS CATHETER KITS
  • Manufacturer
    ABBOTT LABORATORIES HOSPITAL PRODUCTS DIV.

Manufacturer

ABBOTT LABORATORIES HOSPITAL PRODUCTS DIV.
  • Manufacturer Address
    NORTH CHICAGO
  • Source
    HC