Baxter Healthcare Corp. recalls Automated peritoneal dialysis (APD) cycler

Recall date

February 16, 2016

Source

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

Recall number

Z-1565-2016

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

US Consignee: NY ***Foreign Consignee: Ecuador

Why it was recalled

Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot

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

What was recalled

Automated peritoneal dialysis (APD) cycler