BAXTER HEALTHCARE CORPORATION: Sharesource Connectivity Platform for Use with the Amia Automated PD System

Is my product affected?

Sharesource Connectivity Platform for Use with the Amia Automated PD System

• UPC 45413765565692
• UPC 55413765565699

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling the AMIA Sharesource User Guide used with the AMIA Automated PD System cyclers because the guide contains incorrect information about how the UF (Ultrafiltration) Limit setting functions in the cycler's Extra Last Drain Mode. In certain sections of the guide, it incorrectly states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain and allow the patient to end therapy or proceed to their last fill.

The recall affects one unit with product code 5C9400 and UDI numbers 45413765565692 and 55413765565699, and the product was distributed worldwide in the US and Japan. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. Distribution: Worldwide distribution - US Nationwide distribution and the country of Japan. Quantity: 1 unit Lot/code info: Product Code 5C9400, UDI: 45413765565692, 55413765565699

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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