FDA recall Z-2174-2021

Product

Kaguya Automated Peritoneal Dialysis System

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.

Key facts

Status

Terminated

Initiation date

2021-06-30

Report date

2021-08-11

Termination date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Round Lake, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2174-2021