Baxter Healthcare Corporation: Medical Device Recall in 2019 - (Recall #: Z-0849-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

Product Classification:

Class II

Date Initiated: December 11, 2018

Date Posted: February 27, 2019

Recall Number: Z-0849-2019

Event ID: 81738

Reason for Recall:

Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy

Status: Terminated

Product Quantity: 7,688 devices

Code Information:

Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.

Distribution Pattern:

Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated