Events

Recall of HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MCARTHUR MEDICAL SALES 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
    22980
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-27
  • 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
    Cracks in silicon extension tubing of hemodialysis catheters propagate over time resulting in holes because of inadequate use during the insertion procedure that is the extension line clamp is clamped onto the guidewire. the hole in the extension tubing leaks when the device is being pressurized with a syringe during flushing or during dialysis treatment.

Device

HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
  • Model / Serial
    Model Catalog: SL15E (Lot serial: ALL); Model Catalog: SL24P (Lot serial: ALL); Model Catalog: SL12P (Lot serial: ALL); Model Catalog: SL18P (Lot serial: ALL); Model Catalog: SL24C (Lot serial: ALL); Model Catalog: SL20C (Lot serial: ALL); Model Catalog: SL15C (Lot serial: ALL); Model Catalog: SL32 (Lot serial: ALL); Model Catalog: SL28 (Lot serial: ALL); Model Catalog: MC101241 (Lot serial: ALL); Model Catalog: SDL138E (Lot serial: ALL); Model Catalog: SDL136E (Lot serial: ALL); Model Catalog: MC101243 (Lot serial: ALL); Model Catalog: MC101242 (Lot serial: ALL); Model Catalog: SDL139E (Lot serial: ALL)
  • Product Description
    HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
  • Manufacturer
    MCARTHUR MEDICAL SALES INC.

Manufacturer

MCARTHUR MEDICAL SALES INC.