Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set… recallZ-0550-2024 · Baxter Healthcare Corporation · initiated Nov 15, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0550-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 15, 2023
- Posted by the FDA
- Dec 14, 2023
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 339,936 devices
- Product code
- FKX
- FDA submissions
- K151525
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Amia Automated PD Set with Cassette 5C5479Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 recall976 reports
Other devices under the same FDA submission
4 devices cleared under K151525 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Sharesource Connectivity Platform 5C9400Baxter International Inc. · System, peritoneal, automatic delivery1 recall0 reports
- Sharesource Connectivity Platform 5C9400Baxter International Inc. · System, peritoneal, automatic delivery1 recall0 reports
- AMIA Automated PD Cycler 5C9320Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY7 deaths43 reports
- Sharesource Connectivity Platform 5C9400Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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