The Recall Desk

FDA (Devices) recall action 85514

Baxter Healthcare Corporation recalled 4 products on 2020-06-10

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-06-10
Critical
0
Units
2,439,645

Why these products were recalled

Potential disconnection of tubing set.

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

1–4 of 4

  • HighFDA (Devices)··2020-06-10

    Baxter Gambro Cartridge Blood Transport System Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems due to a potential disconnection of the tubing set. The recall covers 53,895 units distributed worldwide.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 19,800 Gambro Cartridge Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 4,065 Gambro Cartridge Low Weight-Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2020-06-10

    Baxter Gambro Cartridge Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential tubing disconnection hazard during hemodialysis treatment.

    Product
    Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Distribution
    43 states