Events

Recall of Device Recall HomeChoice PRO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Renal Div.

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
    30693
  • Event Risk Class
    Class 2
  • Event Number
    Z-0397-05
  • Event Initiated Date
    2004-12-23
  • Event Date Posted
    2005-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36407
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Peritoneal, Automatic Delivery - Product Code FKX
  • Reason
    A software anomaly may allow concentrated solution to be infused into the patient when the homechoice unit is used with physioneal clear-flex pd products.
  • Action
    Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.

Device

Device Recall HomeChoice PRO
  • Model / Serial
    Units with software version 8.7 used with Physioneal Clear-Flex PD products
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.
  • Product Description
    HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA