Baxter Healthcare Corp.: Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

Recall number

Z-0291-2016

Recalling firm

Baxter Healthcare Corp.

Product

Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

Status

Terminated

Initiated

2015-06-29

Posted

2015-11-17

Terminated

2017-01-24

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.

Root 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

29355

Distribution

Nationwide Distribution, District of Columbia, and Puerto Rico.

Lot, serial or model codes

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

510(k) numbers

["K102936"]

PMA numbers

not on file

Product code

FKX

Firm FEI

1417572

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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