Events

Recall of HOMECHOICE AUTOMATED PD SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER 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
    26022
  • Event Risk Class
    II
  • Event Initiated Date
    2000-08-02
  • 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
    For patients with fill volume of 500mls or less a drain phase ends once the flow rate is less than 25 mls/min for at least one minute although these patients may normally drain slower than 25 mls/min.

Device

HOMECHOICE AUTOMATED PD SYSTEM
  • Model / Serial
    Model Catalog: 5C4471 (Lot serial: ALL)
  • Product Description
    HOMECHOICE AUTOMATED PERITONEAL DIAL SY
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION