Z-1039-2015Class II

Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path

Name: Z-1039-2015 Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path
Creator: Baxter Healthcare Corp.
Published: 2014-12-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-12-08 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of... on 2014-12-08. FDA classified it as Class II and gives the reason as "Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1039-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Posted: 2015-02-02
Terminated: 2015-10-28
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter sent an Urgent Product Recall notification letter dated January 8, 2015 . The letter identified the affected product, problem and action to be taken. The recalling firm has asked the consignees to 1) locate and remove all affected product from their facilities, 2) contact Baxter to arrange for return and credit, and 3) complete the attached customer reply form and return it to Baxter. For questions call 800-422-9637.
Quantity in commerce: 8,640 units
Distribution: US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.
Product codes and lots: H13L22013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1039-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1039-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-02

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)