The Recall Desk

FDA (Devices) recall action 91222

Baxter Healthcare Corporation recalled 2 products on 2022-12-28

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
2022-12-28
Critical
0
Units
4,060,488

Why these products were recalled

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

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

  • HighFDA (Devices)··2022-12-28

    Revaclear 400 Dialyzer recall due to potential internal blood leaks

    Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.

    Product
    Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2022-12-28

    Revaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks

    Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.

    Product
    Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
    Category
    Distribution
    1 state