FDA Device recall Z-2173-2021
Sharesource Connectivity Platform for Use with the Amia Automated PD System
- FDA Device
- Class II
- terminated
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class II recall of Sharesource Connectivity Platform for Use with the Amia Automated PD System by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2173-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-30 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Reason
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.
Identifiers
| code_info | Product Code 5C9400, UDI: 45413765565692, 55413765565699 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2021%22
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