Events

Recall of Device Recall Baxter Healthcare Corporation

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

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
    71818
  • Event Risk Class
    Class 3
  • Event Number
    Z-0291-2016
  • Event Initiated Date
    2015-06-29
  • Event Date Posted
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139148
  • 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
    Loud operating sounds, which was unacceptable to the end users when the device was powered on. the homechoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. may delay treatment if changing to a different system.
  • Action
    Baxter sent an Important Product Information communication to affected customers (patients and clinicians) via U.S.P.S., first-class mail on June 29, 2015. The letter states that Baxter Healthcare Corporation is updating the HomeChoice Patient At-Home Guide to include a discussion of the expected operating sounds associated with the HomeChoice and HomeChoice PRO devices. The new labeling will address the following: The HomeChoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the HomeChoice cycler. There will be sounds like humming, swishing, clicking, and venting (air being released) that are normal for the operation of the cycler. In certain portions of the therapy, the sound level is expected to increase which is also part of normal operation. If there is a significant change in the sound level or a new, previously unheard sound when using the HomeChoice cycler, please contact your doctor and/or nurse or Baxter Technical Services. The firm advises customers to keep the letter with the Patient At-Home Guide. The firm also requests that customers complete the enclosed home patient reply form (enclosure) and return it to Baxter by faxing the reply form to 224-270-5457, scanning and e-mailing it to fca@baxter.com or by mail in the enclosed, preaddressed, stamped envelope. Returning the home patient reply form promptly will prevent you from receiving repeat notices. If the customer has any questions about their Peritoneal Dialysis (PD) therapy, they are advised to please contact their doctor and/or nurse. Additionally the letter states that any adverse reactions or quality problems experienced with the use of this product may be reported using one of the following options: " Calling Baxter Product Surveillance at 800-437-5176, Monday through Friday, between 8:00 am and 5:30 pm Central Time Baxter will advise customers of the additional product information regarding

Device

Device Recall Baxter Healthcare Corporation
  • Model / Serial
    All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R.   Dates Distributed: 1994 to present  Quantity Distributed: All
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, District of Columbia, and Puerto Rico.
  • Product Description
    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA