The Recall Desk

FDA (Devices) recall action 81240

Baxter Healthcare Corporation recalled 5 products on 2018-11-07

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2018-11-07
Critical
0
Units
1,142,518

Why these products were recalled

Potential ability to leak once used for compounding.

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

1–5 of 5

  • HighFDA (Devices)··2018-11-07

    Baxter Recalls EXACTAMIX Empty EVA Bags Due to Potential Leaking

    Baxter Healthcare is recalling 281,350 units of EXACTAMIX Empty EVA Bags because they may leak after being used for compounding.

    Product
    EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 158,163 units of Exactamix Empty EVA Bags because they may leak after being used for compounding.

    Product
    EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 136,800 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 456,071 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 110,134 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Distribution
    50 states