Events

Recall of THORACENTESIS/PARACENTESIS TRAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    26250
  • Event Risk Class
    II
  • Event Initiated Date
    2002-11-18
  • 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
    Manufacturer has identified that these catheters could be brittle thus creating a potential for breakage during use.

Device

THORACENTESIS/PARACENTESIS TRAY
  • Model / Serial
    Model Catalog: P4341B (Lot serial: L2B047 L2B073 L2C012); Model Catalog: P4341B (Lot serial: 8 L1K070 L1L057X L1N018); Model Catalog: P4341B (Lot serial: L1N031 L2E036.); Model Catalog: P4341B (Lot serial: L2C038 L2C083 L2D041 L2D067); Model Catalog: P4341B (Lot serial: L1J035X L1J088 L1K042 L1K05); Model Catalog: P4341B (Lot serial: L2A021 L2A048 L2A075 L2B039); Model Catalog: P4341B (Lot serial: 7 L1P045 L1S015 L2A012); Model Catalog: P4341B (Lot serial: L1N031 L1N039X L1N094 L1P01)
  • Product Description
    THORACENTESIS/PARACENTESIS TRAY
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC