Baxter Healthcare Corp.: 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Recall number

Z-2609-2016

Recalling firm

Baxter Healthcare Corp.

Product

1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Status

Terminated

Initiated

2013-10-07

Posted

not on file

Terminated

2016-12-23

Reason

In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.

Root cause

Labeling design

Action

An IMPORTANT PRODUCT INFORMATION letter dated October 7, 2013, was sent to all affected customers. The letter included instructions for clinicians to: 1) be aware that HomeChoice will attempt to drain the patient to empty at the beginning of therapy (Initial Drain); 2) review HomeChoice instructions for use for additional details on HomeChoice 10.4 Initial Drain Logic; 3) acknowledge your receipt of the notification by completing the attached Customer Reply Form and returning by fax to either 224-270-5457 or scanning and e-mailing it to fca@baxter.com; 3) if the recipient of the letter is a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, to forward the communication to all customers who may have received these products. Clinical questions should be addressed to Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00PM CST). General questions about this recall should be addressed to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).

Quantity

*** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units

Distribution

Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan

Lot, serial or model codes

*** 1) HomeChoice automated peritoneal dialysis system:  Product Codes: 5C4471 and 5C4471R;  Serial Numbers: All serial numbers;   *** 2) HomeChoice Pro automated peritoneal dialysis system:  Product Codes: 5C8310 and 5C8310R;  Serial Numbers: All serial numbers

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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