Events

Recall of HICKMAN SUBCUTANEOUS TITANIUM PORTS AND CATHETERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    32105
  • Event Risk Class
    III
  • Event Initiated Date
    2011-09-23
  • 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
    There is a labeling discrepancy specific to listed lot numbers of bardport titanium implanted port (pc 0602290). the end flap label indicates a different product description as compared to the main label. the main label identifies the port as a "titanium implanted port" while the end flap identifies the port as a "titanium low-profile implanted port". the product inside the kit is a regular port and not a low-profile port.

Device

HICKMAN SUBCUTANEOUS TITANIUM PORTS AND CATHETERS
  • Model / Serial
    Model Catalog: 0602290 (Lot serial: RETA0584); Model Catalog: 0602290 (Lot serial: RESF1061); Model Catalog: 0602290 (Lot serial: RESI0209); Model Catalog: 0602290 (Lot serial: RESK0806)
  • Product Description
    BARDPORT TITANIUM IMPLANTED PORT
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.