BAXTER HEALTHCARE CORPORATION Recall 88219
Description: Sharesource Connectivity Platform for Use with the Amia Automated PD System
BAXTER HEALTHCARE CORPORATION Recall 88219 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2173-2021 |
| Event ID | 88219 |
| Event Description | Sharesource Connectivity Platform for Use with the Amia Automated PD System |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Japan. |
| Quantity | 1 unit |
| Recall 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 cycler s 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. |
| Device Classification | 20210811 |
| Device Code Info | Product Code 5C9400, UDI: 45413765565692, 55413765565699 |
| Center Classification Date | 20210802 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | BAXTER HEALTHCARE CORPORATION |
| Initial Notification | Letter |
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