The Recall Desk

FDA (Devices) recall action 67453

Hospira Inc. recalled 3 products on 2014-06-11

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2014-06-11
Critical
0
Units
—

Why these products were recalled

There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2014-06-11

    Hospira Infusion Pumps Recalled for Door Roller Assembly Defect

    Hospira is recalling specific Plum XL and Micro Macro infusion pumps because a door roller assembly may break, preventing the cassette from locking properly.

    Product
    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patie
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2014-06-11

    Hospira Recalls LifeCare 5000 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling LifeCare 5000 infusion pumps because a broken door roller pin may prevent the door from locking the cassette properly, potentially causing alarms or false occlusions.

    Product
    LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2014-06-11

    Hospira Recalls Infusion Pumps Due to Door Roller Assembly Breakage Risk

    Hospira is recalling specific Plum XL and LifeCare infusion pumps because a door roller assembly may break, preventing the cassette door from locking properly.

    Product
    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, an
    Category
    Distribution
    3 states