FDA Device recall Z-0849-2019
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatm…
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatm… by Baxter Healthcare, citing potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0849-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-11 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
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
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Identifiers
| code_info | Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0849-2019%22
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