Z-2609-2016Class II

1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part...

Name: Z-2609-2016 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part...
Creator: Baxter Healthcare Corp.
Published: 2013-10-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-10-07 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal... on 2013-10-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2609-2016
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Posted: 2016-08-22
Terminated: 2016-12-23
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected]; 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 in commerce: *** 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
Product codes and lots: *** 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2609-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2609-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22

Product code FKX

K102936Class IIHomechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471r and 5C8310rBaxter Healthcare Corp / cleared 2011-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)