AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions
The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device user guide containing incorrect operating instructions for a critical peritoneal dialysis system. While no injuries or illnesses have been reported, the potential for harm exists if patients operate the device based on inaccurate instructions. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation has recalled the AMIA Sharesource User Guide distributed with the AMIA Automated Peritoneal Dialysis System due to inaccurate instructions. The guide incorrectly states in some locations that the Ultrafiltration (UF) volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain Mode, which would then allow the patient to end therapy or proceed to their last fill.
The recall affects approximately 5,101 units distributed worldwide, including throughout the United States and Japan. The manufacturer identified the documentation error and issued a Class II recall to ensure patients and healthcare providers have accurate operating information.
Patients using the AMIA Automated Peritoneal Dialysis System should contact their healthcare provider to verify the correct procedures for using the Ultrafiltration Limit setting and ending therapy. Baxter Healthcare Corporation is providing accurate information to correct the documentation error.
The recalled product
- Product
- Kaguya Automated Peritoneal Dialysis System
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Affected units
- 5,101
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code T5C8500 (distribution in Japan only)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by BAXTER HEALTHCARE CORPORATION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · BAXTER HEALTHCARE CORPORATION
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- HighBaxter AMIA Automated Peritoneal Dialysis System Software Recall
FDA (Devices) · 2019-02-27
- ModerateBaxter APD Cycler Recall for Incomplete Clinician Guide Instructions
FDA (Devices) · 2016-05-04
- SevereBaxter Recalls Kaguya Automated Peritoneal Dialysis Systems Due to Software Defect
FDA (Devices) · 2019-02-27
- ModerateBaxter AMIA v1.0 APD System Recall for Labeling Warning
FDA (Devices) · 2015-03-11
- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Amia Automated PD Systems Recalled for Battery Charging Error
FDA (Devices) · 2015-01-14