Z-3133-2017Class II

Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

Name: Z-3133-2017 Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Creator: Baxter Healthcare Corp
Published: 2017-09-01
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2017-09-01 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp began a recall of Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 on 2017-09-01. FDA classified it as Class II and gives the reason as "The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3133-2017
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Posted: 2017-09-14
Terminated: 2019-08-27
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Quantity in commerce: 164,700 units
Distribution: nationwide, Canada
Product codes and lots: Lot numbers: H16G28107, H16H01086, H16H04114, H16H09063, H16H13032, H16H19112, H16H26034, H16H30010, H16I02017, H16I06018, H16I08071, H16I12016, H16I14103, H16I16066, H16I19060, H16I21058, H16I23047, H16I26065, H16I30091, H16J03014, H16J05035, H16J07015, H16J09078, H16J11132, H16J14011, H16J16057, H16J18046, H16J20109, H16J22063, H16J24127, H16J26072, H16J28128, H16J30058, H16K01057, H16K03079, H16K05041, H16K07054, H16K08086, H16K10090, H16K28027, H16K30015, H16L04034, H16L11039, H16L15105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3133-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3133-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-14

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)