The Recall Desk

FDA (Devices) recall action 87150

Baxter Healthcare Corporation recalled 6 products on 2021-02-24

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2021-02-24
Critical
0
Units
7,734,090

Why these products were recalled

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

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.

1–6 of 6

  • HighFDA (Devices)··2021-02-24

    Baxter Gambro Hemodialysis Blood Set Recalled for Kinked Access Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Volume Blood Transport Systems for hemodialysis due to reports of kinked access lines during treatment.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-24

    Baxter Gambro Cartridge Single Needle Conversion Kit Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Single Needle Conversion Kits due to reports of kinked access lines during hemodialysis treatments.

    Product
    Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to reports of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-24

    Baxter Recalls Gambro Hemodialysis Blood Sets Due to Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis because of complaints regarding kinked access lines observed during treatment.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to complaints of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-02-24

    Baxter Gambro Cartridge Blood Set Prime Line Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Set Prime Line units because kinked access lines were observed during hemodialysis treatments.

    Product
    Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Distribution
    0 states