Z-0849-2019 Class II Terminated
FDA device recall Z-0849-2019 was initiated by Baxter Healthcare Corporation on Dec 11, 2018 and is designated Class II. Reason for recall: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy The recall status is terminated (terminated Feb 12, 2021). Affected quantity: 7,688 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Dec 11, 2018
- Termination Date
- Feb 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,688 devices
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.
Reason for Recall
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
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.
Code Information
Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0849-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026