Z-1245-2015Class II

AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients

Name: Z-1245-2015 AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients
Creator: Baxter Healthcare Corp.
Published: 2014-04-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-04-03 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients on 2014-04-03. FDA classified it as Class II and gives the reason as "Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any...". 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-1245-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Posted: 2015-03-04
Terminated: 2017-07-21
Recalling firm: Baxter Healthcare Corporation
Product: AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Product code: FIK System, Dialysate Delivery, Recirculating
Reason for recall: Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Baxter sent IMPORTANT PRODUCT INFORMATION letters dated April 3, 2014 to all peritoneal dialysis healthcare providers of record. The letters advised healthcare providers of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the healthcare providers to complete and return the attached Customer Reply Form. Healthcare providers with clinical questions can contact Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2, 8:00 AM - 5:00 PM CT. Healthcare providers with general questions can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT. Additionally, an IMPORTANT PRODUCT INFORMATION letters dated April 8, 2014 were sent to all peritoneal dialysis patients of record. The letters advised patients of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the patients to complete and return the attached Home Patient Reply Form. Patients with questions about the letter can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT.
Quantity in commerce: 55 systems
Distribution: US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
Product codes and lots: Product Code: 5C9310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1245-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-04

Product code FIK

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)