Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2173-2021 — Sharesource Connectivity Platform for Use with the Amia Automated PD System

U.S. FDA — Device Enforcement · United States · 2021-06-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2173-2021
Date of alert
2021-06-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
BAXTER HEALTHCARE CORPORATION
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
45413765565692
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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