The Recall Desk

FDA (Devices) recall action 69786

Gambro Renal Products Inc recalled 2 products on 2014-12-10

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
2014-12-10
Critical
0
Units
40

Why these products were recalled

Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.

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)··2014-12-10

    Gambro Recalls Polyflux Dialyzers Due to Potential Packaging Tears

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-12-10

    Gambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Distribution
    1 state