The Recall Desk

FDA (Devices) recall action 95192

Baxter Healthcare Corporation recalled 4 products on 2024-09-25

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2024-09-25
Critical
1
Units
13,097,651

Why these products were recalled

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

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.

1–4 of 4

  • SevereFDA (Devices)··2024-09-25

    Baxter EXACTAMIX Inlet Compounders Recalled for Particulate Matter Contamination

    Baxter Healthcare is recalling EXACTAMIX Inlet components (H938173 and related codes) due to particulate matter contamination observed in the sterile fluid path before use. Approximately 3.58 million units distributed worldwide are affected.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2024-09-25

    Baxter EXACTAMIX pharmaceutical compounding inlets recalled for particulate contamination

    Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2024-09-25

    Baxter pharmaceutical compounding inlets recalled for particulate matter contamination

    Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2024-09-25

    Baxter ExactaMix Inlets Recalled for Particulate Contamination Risk

    Baxter Healthcare is recalling ExactaMix pharmaceutical compounding device inlets due to increased reports of particulate matter in the sterile fluid path before use. The recall involves 2,140,046 units with worldwide distribution.

    Product
    Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
    Category
    Distribution
    0 states