Class 3 Device Recall Baxter Healthcare Corporation

• Date Initiated by Firm: June 29, 2015
• Date Posted: November 17, 2015
• Recall Status: Terminated on January 24, 2017
• Recall Number: Z-0291-2016
• Recall Event ID: 71818
• 510(K)Number: K102936
• Product Classification: System, peritoneal, automatic delivery - Product Code FKX
• Product: Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
• Code Information: 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
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center For One Baxter; 800-422-9837
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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
• Quantity in Commerce: 29355
• Distribution: Nationwide Distribution, District of Columbia, and Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FKX and Original Applicant = BAXTER HEALTHCARE CORP.