medical Class II Updated 2021-08-11

BAXTER HEALTHCARE CORPORATION recalls Sharesource Connectivity Platform for Use with the Amia Auto

Recalled Product

Sharesource Connectivity Platform for Use with the Amia Automated PD System


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code 5C9400, UDI: 45413765565692, 55413765565699
View official government recall

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