FDA Device recall Z-0850-2019
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the trea…
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the trea… 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-0850-2019 |
| 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
Kaguya 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 T5C8500. All serial numbers are affected. |
|---|
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-0850-2019%22
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