FDA Device recall Z-0550-2024
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 by Baxter Healthcare, citing there is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0550-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-15 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Reason
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Identifiers
| code_info | UDI/DI 0085412153186, Lot Numbers: H23F23028, H23G11054, H23F24018, H23G12029, H23F24034, H23G13100, H23F24067, H23G…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0550-2024%22
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