The Recall Desk

FDA (Devices) recall action 81738

Baxter Healthcare Corporation recalled 2 products on 2019-02-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-02-27
Critical
0
Units
8,773

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2019-02-27

    Baxter Recalls Kaguya Automated Peritoneal Dialysis Systems Due to Software Defect

    Baxter Healthcare is recalling 1,085 Kaguya Automated Peritoneal Dialysis Systems because a software defect may cause shortened dwell times during therapy.

    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.
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2019-02-27

    Baxter AMIA Automated Peritoneal Dialysis System Software Recall

    Baxter is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems due to a software defect that may cause shortened dwell times during therapy.

    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.
    Category
    Distribution
    51 states