The Recall Desk

FDA (Devices) recall action 69181

Baxter Healthcare Corp recalled 2 products on 2014-11-12

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
2014-11-12
Critical
0
Units
114,672

Why these products were recalled

Particulate matter found inside the fluid path.

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)··2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Distribution
    1 state