Z-0550-2024 Class II Ongoing
FDA device recall Z-0550-2024 was initiated by Baxter Healthcare Corporation on Nov 15, 2023 and is designated Class II. Reason for recall: There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. The recall status is ongoing. Affected quantity: 339,936 devices.
Recall details
- Product Type
- Devices
- Report Date
- Dec 20, 2023
- Initiation Date
- Nov 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 339,936 devices
Product description
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Reason for recall
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0550-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026