Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-1565-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Automated peritoneal dialysis (APD) cycler

Product Classification:

Class II

Date Initiated: February 16, 2016

Date Posted: May 4, 2016

Recall Number: Z-1565-2016

Event ID: 73435

Reason for Recall:

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

Status: Terminated

Product Quantity: 10 units

Code Information:

N/A

Distribution Pattern:

US Consignee: NY ***Foreign Consignee: Ecuador

Voluntary or Mandated:

Voluntary: Firm initiated