Recall Z-3133-2017— Baxter Healthcare Corp

Name: FDA recall Z-3133-2017
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp, initiated 2017-09-01, terminated 2019-08-27. It names one FDA 510(k) clearance: K151525. Product: Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479. Reason: The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette..

Recalling firm: Baxter Healthcare Corp
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Terminated: 2019-08-27
Firm location: Mountain Home, AR, 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 Set with Cassette, REF 5C5479

Reason for recall

The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.

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