Recall Z-0850-2019— Baxter Healthcare Corporation
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-12-11, terminated 2021-02-12. It names one FDA 510(k) clearance: K151525. 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.
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-11
- Terminated
- 2021-02-12
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Data sourced from openFDA. This site is unofficial and independent of the FDA.