Recall Z-0550-2024— Baxter Healthcare Corporation

Name: FDA recall Z-0550-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-15

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-11-15. It names one FDA 510(k) clearance: K151525. Product: Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479. Reason: There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-11-15
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K151525 — Amia Automated PD System with SharesourceDeka Research and Development·cleared 2015-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Reason for recall

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.