CLASS II Device recall · Reported 11 Aug 2021 · FDA Enforcement Report

Kaguya Automated Peritoneal Dialysis System recalled

Baxter Healthcare is recalling Kaguya Automated Peritoneal Dialysis System, distributed nationwide in the US. The recall was initiated on 30 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code T5C8500 (distribution in Japan only)

Quantity recalled5101 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2174-2021
FDA event ID: 88219
Recalling firm: Baxter Healthcare, Round Lake, IL
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2021
FDA classified: 2 Aug 2021
Reported: 11 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Jun 2021	Recall initiated by company
2 Aug 2021	Classified by FDA	+33 days
11 Aug 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Kaguya Automated Peritoneal Dialysis System

Where it was distributed

Worldwide distribution - US Nationwide distribution and the country of Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Product Code T5C8500 (distribution in Japan only)

Where was it sold?

Worldwide distribution - US Nationwide distribution and the country of Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88219

This product is part of a recall event; the main page for the event is Sharesource Connectivity Platform for Use recalled by Baxter Healthcare.

Reported	Class	Recall	Company	Reason	Where
11 Aug 2021	CLASS II	Sharesource Connectivity Platform for Use recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide

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