Z-0550-2024Class II

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Name: Z-0550-2024 Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Creator: Baxter Healthcare Corporation
Published: 2023-11-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-11-15 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 on 2023-11-15. FDA classified it as Class II and gives the reason as "There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0550-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-15
Posted: 2023-12-14
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter issued an Urgent Medical Device Recall notice to its consignees on 11/15/2023 by US Mail. The notice explained the issue, potential risk, and requested the following: Isolate and cease all use of the affected units pending return.
Quantity in commerce: 339,936 devices
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI/DI 0085412153186, Lot Numbers: H23F23028, H23G11054, H23F24018, H23G12029, H23F24034, H23G13100, H23F24067, H23G14074, H23F25049, H23G15048, H23F25056, H23G16038, H23F26047, H23G17051, H23F26054, H23G18067, H23F27037, H23G19115, H23F27045, H23G20055, H23F27102, H23G22069, H23F28035, H23G23067, H23F28043, H23G24107, H23F29066, H23G25047, H23F30064, H23G25096, H23G01030, H23G26094, H23G02046, H23G27100, H23G05015, H23G28082, H23G06047, H23G30054, H23G07052, H23G31110, H23G08050, H23H04032, H23G09058, H23H05039, H23G10072

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0550-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0550-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-14

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