The Recall Desk

FDA (Devices) recall action 71543

Elite Biomedical Solutions LLC recalled 2 products on 2015-08-26

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
2015-08-26
Critical
1
Units
955

Why these products were recalled

Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

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)··2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Frame Membranes

    Elite Biomedical Solutions LLC is recalling 609 Alaris Medley LVP Frame Membranes because the defect could allow fluid intrusion, potentially leading to injury or death.

    Product
    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Distribution
    21 states
  • CriticalFDA (Devices)··2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies

    Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.

    Product
    Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Distribution
    21 states