Z-1565-2016Class II

Automated peritoneal dialysis (APD) cycler

Name: Z-1565-2016 Automated peritoneal dialysis (APD) cycler
Creator: Baxter Healthcare Corp.
Published: 2016-02-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-02-16 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Automated peritoneal dialysis (APD) cycler on 2016-02-16. FDA classified it as Class II and gives the reason as "Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1565-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-16
Posted: 2016-04-25
Terminated: 2016-12-23
Recalling firm: Baxter Healthcare Corporation
Product: Automated peritoneal dialysis (APD) cycler
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
FDA root cause: Under Investigation by firm
Action: An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter.
Quantity in commerce: 10 units
Distribution: US Consignee: NY ***Foreign Consignee: Ecuador
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1565-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-25

Product code FKX

K151525Class IIAmia Automated PD System with SharesourceDeka Research and Development / cleared 2015-10-09

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)