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 cycler s 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.
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📍Recalling firmBAXTER HEALTHCARE CORPORATION25212 W Il Route 120 · Round Lake, IL 60073-9799
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/62260-baxter-sharesource-connectivity-platform-recall-incorrect-uf-limit-setting-description.
“Baxter Sharesource Connectivity Platform Recall: Incorrect UF Limit Setting Description.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62260-baxter-sharesource-connectivity-platform-recall-incorrect-uf-limit-setting-description. Based on FDA recall #Z-2173-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2021%22&limit=1).
The FDA announced on June 30, 2021, that Baxter Healthcare Corporation is recalling the Sharesource Connectivity Platform for Use with the Amia Automated PD System. The hazard involves an incorrect description of the Ultrafiltration Limit setting in the user guide.
How to tell if you have it
Brand: Baxter Healthcare
Product: Sharesource Connectivity Platform for Use with the Amia Automated PD System
Product Code: 5C9400
UDI: 45413765565692, 55413765565699
The hazard
The AMIA Sharesource User Guide incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria for the cycler's Extra Last Drain Mode. The guide states that the UF volume achieved must exceed the programmed UF Limit before the cycler ends the Extra Last Drain, allowing patients to end therapy or proceed to their last fill.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Other recent recalls of similar products include PRO+ MRS SURFACE FOR VERSACARE (August 18, 2026), 0.9% Sodium Chloride Injection (August 17, 2026), and Dextrose 2000mL Bags (August 17, 2026). Other recent recalls of similar products include Fresenius 5008X Blood Tubing Set (May 11, 2026).
How to tell if you have this one
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.
Brand
Baxter Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the country of Japan.
Recall number
Product, codes & lots
Quantity
Z-2173-2021
Sharesource Connectivity Platform for Use with the Amia Automated PD System; Product Code 5C9400, UDI: 45413765565692, 55413765565699
1 unit
Z-2174-2021
Kaguya Automated Peritoneal Dialysis System; Product Code T5C8500 (distribution in Japan only)
5101 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code (5C9400) or UDI number (45413765565692 or 55413765565699) on the Sharesource Connectivity Platform.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Is there a risk of serious injury?
The recall is for potential therapy errors, but the hazard does not describe a risk of serious injury. The danger level is low risk.
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.
Official source: FDA Recall #Z-2173-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2173-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.