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Terminated

Kaguya Automated Peritoneal Dialysis System

FDA Recall Z-2174-2021 · Posted None

Recalling FirmBAXTER HEALTHCARE CORPORATION
Recall StatusTerminated
Product CodeFKX
Date Initiated2021-06-30
Date Terminated2024-04-10
Product Quantity5101 units

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.

Firm Action

The firm notified its consignees by letter on 06/30/2021. The letter explained the issue with the instructions for use, specifically, That the AMIA Sharesource User Guide describes the function of the UF (ultrafiltration) Limit setting as the ending criteria of the cycler's Extra Last Drain Mode. Baxter will be sending a Follow-Up communication once the AMIA Sharesource User Guide has been updated on the portal.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the country of Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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