PlainRecalls
FDA Devices Moderate Class II Terminated

Sharesource Connectivity Platform for Use with the Amia Automated PD System

Reported: August 11, 2021 Initiated: June 30, 2021 #Z-2173-2021

Product Description

Sharesource Connectivity Platform for Use with the Amia Automated PD 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.

Details

Units Affected
1 unit
Distribution
Worldwide distribution - US Nationwide distribution and the country of Japan.
Location
Round Lake, IL

Frequently Asked Questions

What product was recalled?
Sharesource Connectivity Platform for Use with the Amia Automated PD System. Recalled by BAXTER HEALTHCARE CORPORATION. Units affected: 1 unit.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 11, 2021. Severity: Moderate. Recall number: Z-2173-2021.