Baxter Healthcare recalls Sharesource Connectivity Platform for Amia Automated PD Systems due to incorrect UF Limit setting description in user guide, potentially causing therapy errors.
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.
Baxter Healthcare is recalling the Sharesource Connectivity Platform for Amia Automated PD Systems because the user guide incorrectly describes the Ultrafiltration (UF) Limit setting. This could lead to patients ending therapy prematurely or proceeding to their last fill when they shouldn't. The recall is for specific product codes.
The user guide incorrectly states that the UF volume must exceed the programmed UF Limit before ending the Extra Last Drain. This could cause patients to end therapy prematurely or proceed to their last fill when they shouldn't, potentially leading to treatment errors.
Healthcare providers using the Amia Automated PD Systems with the Sharesource Connectivity Platform are affected. Patients using these systems may be at risk if the incorrect setting leads to therapy errors.
Check for product codes 5C9400 or UDI numbers 45413765565692 and 55413765565699 on the Sharesource Connectivity Platform. This product is used with Amia Automated PD Systems.
Verify the product code (5C9400) or UDI number (45413765565692 or 55413765565699) on the Sharesource Connectivity Platform.
The user guide incorrectly describes the Ultrafiltration (UF) Limit setting, which could cause patients to end therapy prematurely or proceed to their last fill when they shouldn't.
Check the product code or UDI number to confirm if it's affected. The recall does not include a specific remedy, so no action is required beyond verification.
The recall is for potential therapy errors, but the hazard does not describe a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2173-2021 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-2173-2021 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
