Z-2174-2021 Class II Terminated
FDA device recall Z-2174-2021 was initiated by BAXTER HEALTHCARE CORPORATION on Jun 30, 2021 and is designated Class II. Reason for recall: Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration)… The recall status is terminated (terminated Apr 10, 2024). Affected quantity: 5101 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 11, 2021
- Initiation Date
- Jun 30, 2021
- Termination Date
- Apr 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5101 units
Product description
Kaguya Automated Peritoneal Dialysis System
Reason for recall
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
Distribution pattern
Worldwide distribution - US Nationwide distribution and the country of Japan.
Code information
Product Code T5C8500 (distribution in Japan only)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2174-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026