Baxter Healthcare Corp.: Medical Device Recall in 2015 - (Recall #: Z-1245-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

Product Classification:

Class II

Date Initiated: April 3, 2014

Date Posted: March 11, 2015

Recall Number: Z-1245-2015

Event ID: 70194

Reason for Recall:

Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.

Status: Terminated

Product Quantity: 55 systems

Code Information:

Product Code: 5C9310

Distribution Pattern:

US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)

Voluntary or Mandated:

Voluntary: Firm initiated