The Recall Desk

FDA (Devices) recall action 83015

Baxter Healthcare Corporation recalled 2 products on 2019-07-10

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
2019-07-10
Critical
0
Units
1,314,675

Why these products were recalled

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

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.

1–2 of 2

  • HighFDA (Devices)··2019-07-10

    Baxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 400 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-07-10

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Distribution
    0 states