Events

Recall of WHISTLE TIP CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL 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
    47695
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-15
  • 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
    Although the product labeling identifies the catheters as "soft rubber" the natural rubber latex caution statement ("caution: this product contains natural rubber latex which may cause allergic reactions") was not printed on the product label. if a person with a latex sensitivity comes into contact with the latex component of the product an allergic reaction could occur.

Device

WHISTLE TIP CATHETER
  • Model / Serial
    Model Catalog: 403900120 (Lot serial: 13261); Model Catalog: 403900100 (Lot serial: 13451); Model Catalog: 403900120 (Lot serial: 13451); Model Catalog: 403900100 (Lot serial: 13511); Model Catalog: 403900120 (Lot serial: 13511); Model Catalog: 403900100 (Lot serial: 13261); Model Catalog: 403340140 (Lot serial: 14131); Model Catalog: 403300100 (Lot serial: 13311); Model Catalog: 403300100 (Lot serial: 14131); Model Catalog: 403340140 (Lot serial: 14091); Model Catalog: 403300140 (Lot serial: 14091); Model Catalog: 403300100 (Lot serial: 14091); Model Catalog: 403340140 (Lot serial: 14041); Model Catalog: 403300140 (Lot serial: 14041); Model Catalog: 403300100 (Lot serial: 14041); Model Catalog: 403340140 (Lot serial: 13481); Model Catalog: 403300140 (Lot serial: 13481); Model Catalog: 403300100 (Lot serial: 13481); Model Catalog: 403340140 (Lot serial: 13461); Model Catalog: 403300140 (Lot serial: 13461); Model Catalog: 403300100 (Lot serial: 13461); Model Catalog: 403340140 (Lot serial: 13311); Model Catal
  • Product Description
    NELATON WHISTLE TIP CATHETER
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.