Z-1056-2017Class II

APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with...

Name: Z-1056-2017 APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with...
Creator: Baxter Healthcare Corporation
Published: 2016-12-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-12-16 / Terminated / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with... on 2016-12-16. FDA classified it as Class II and gives the reason as "Customer complaints received for the presence of leaks". 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-1056-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2017-01-19
Terminated: 2017-08-24
Recalling firm: Baxter Healthcare Corporation
Product: APD Set with Cassette 3-Prong Peritoneal Dialysis Set 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: Customer complaints received for the presence of leaks
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.
Quantity in commerce: 8640 eaches
Distribution: US only
Product codes and lots: H16F16088

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1056-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-19

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)