The Recall Desk

FDA (Devices) recall action 67996

Gambro Renal Products, Incorporated recalled 2 products on 2014-05-28

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
2014-05-28
Critical
0
Units
4,923,648

Why these products were recalled

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

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)··2014-05-28

    Gambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.

    Product
    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-05-28

    Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.

    Product
    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Distribution
    1 state