Events

Recall of HOMECHOICE PRO 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
    95713
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-24
  • 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
    Baxter is notifying customers of a potential issue with the occluder assembly for specific serial numbers of homechoice pro devices. the occluder may contain sharp edges and/or may separate from the back plate which may cause the occluder assembly to fail resulting in an unrecoverable slow flow/no flow alarm or an unrecoverable system error. the device will fail in a safe position and prevent solution from being delivered to the patient but patient will also not be able to perform/complete therapy.

Device

HOMECHOICE PRO AUTOMATED PD SYSTEM
  • Model / Serial
    Model Catalog: 5C8310P (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    HOMECHOICE PRO AUTOMATED PD SYSTEM
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION