Events

Recall of HOMECHOICE AUTOMATED PD SET WITH CASSETTE

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
    54333
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-25
  • 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 issuing a safety alert to dialysis center clinicians to make them aware of safeguards that should be considered with seizure prone patients and other at-risk patients unable to care for themselves due to transient or permanent impairments during homechoice peritoneal dialysis therapy. this follows a reported patient death linked to tubing entanglement around the neck.

Device

HOMECHOICE AUTOMATED PD SET WITH CASSETTE
  • Model / Serial
    Model Catalog: R5C4478 (Lot serial: ALL LOTS); Model Catalog: R5C4427 (Lot serial: ALL LOTS)
  • Product Description
    AUTOMATED PERITONEAL DIALYSIS SETS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION