Events

Recall of 4818 SUCTION CATHETERS - 18 FR.

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DYNAREX CORPORATION.

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
    20276
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-15
  • 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
    The listed devices are recalled because they were found to be unlicensed in canada.

Device

4818 SUCTION CATHETERS - 18 FR.
  • Model / Serial
    Model Catalog: 4818 (Lot serial: All.); Model Catalog: 5105 (Lot serial: All.); Model Catalog: 4914 (Lot serial: All.); Model Catalog: 5201 (Lot serial: All.); Model Catalog: 5604 (Lot serial: All.); Model Catalog: 5207 (Lot serial: All.); Model Catalog: 4916 (Lot serial: All.); Model Catalog: 5302 (Lot serial: All.); Model Catalog: 4806 (Lot serial: All.); Model Catalog: 4810 (Lot serial: All.); Model Catalog: 5602 (Lot serial: All.); Model Catalog: 5205 (Lot serial: All.); Model Catalog: 5303 (Lot serial: All.); Model Catalog: 4816 (Lot serial: All.); Model Catalog: 4814 (Lot serial: All.); Model Catalog: 5202 (Lot serial: All.); Model Catalog: 5206 (Lot serial: All.); Model Catalog: 4808 (Lot serial: All.); Model Catalog: 4832 (Lot serial: All.); Model Catalog: 5203 (Lot serial: All.); Model Catalog: 4812 (Lot serial: All.)
  • Product Description
    4818 SUCTION CATHETERS - 18 FR.;5105 PXYGEN TUBING - NO CRUSH LUMEN - 25 FT;4914 VAGINAL SPECULUM - S;5201 SOF-TOUCH NASAL CANNULAS INFANT;5604 NEBULIZER WITH ADULT AEROSOL MASK;5207 STANDARD NASAL CANNULAS ADULT FLARED CURBE;4916 VAGINAL SPECULUM - L;530
  • Manufacturer
    DYNAREX CORPORATION

Manufacturer

DYNAREX CORPORATION