Events

Recall of ARTERIAL PRESSURE MONITORING SETS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (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
    109102
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-07
  • 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
    Potential adverse events that may occur as a result of catheter tip fracture and or separation may include loss of device function medical intervention to retrieve a separated segment or complications resulting from a separated tip occluding blood flow to end organs.

Device

ARTERIAL PRESSURE MONITORING SETS
  • Model / Serial
    Model Catalog: C-PMS-251 (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301-FA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301J-FA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-300J-FA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-401J-FA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-400-FA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-300-RA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-300J-RA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301-RA (Lot serial: >10 contact mfr); Model Catalog: C-PMS-300 (Lot serial: >10 contact mfr); Model Catalog: C-PMS-400J (Lot serial: >10 contact mfr); Model Catalog: C-PMS-2502-15-3.5 (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301J (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301J-PED-BH (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301J-PED (Lot serial: >10 contact mfr); Model Catalog: C-PMS-301J-RA (Lot serial: >10 contact mfr)
  • Product Description
    ARTERIAL PRESSURE MONITORING SETS
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.