Baxter Healthcare Corp recalls Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

Recall date

September 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3133-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp

Sold / distributed

nationwide, Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479