Events

Recall of Baxter

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
    69586
  • Event Risk Class
    Class 2
  • Event Number
    Z-0932-2015
  • Event Initiated Date
    2014-04-24
  • Event Date Posted
    2015-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130996
  • 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
    System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
  • Action
    Baxter sent an IMPORTANT PRODUCT INFORMATION letter dated April 24, 2014 to all affected customers. The peritoneal dialysis provider consignees were instructed to: 1) complete the enclosed customer reply form and return it to Baxter; and, 2) contact Baxter Technical Services at 800-553-6898 should a System Event 01179 occur. Baxter Technical Services is available 24 hours a day, 7 days a week. Clinical questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00 PM CT). General questions regarding the Import Product Information letter can be direct to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CT). For questions regarding this recall call 800-422-9837.

Device

Baxter
  • Model / Serial
    Product Code: 5C9310
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
  • Product Description
    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
  • 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