The Recall Desk

FDA (Devices) recall action 67591

Hospira Inc. recalled 2 products on 2014-05-07

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
2014-05-07
Critical
0
Units
26,436

Why these products were recalled

Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.

Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.

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

  • HighFDA (Devices)··2014-05-07

    Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies

    Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.

    Product
    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··2014-05-07

    Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies

    Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.

    Product
    Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
    Category
    Distribution
    47 states