The Recall Desk

FDA (Devices) recall action 63772

Hospira Inc. recalled 3 products on 2013-01-09

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
2013-01-09
Critical
0
Units
326,612

Why these products were recalled

The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.

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

1–3 of 3

  • HighFDA (Devices)··2013-01-09

    Hospira Recalls Plum A+3 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 28,599 Plum A+3 infusion pumps worldwide because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of IV medication.

    Product
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-01-09

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 180 Plum A+ Hyperbaric Infusion Pumps because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of medication.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2013-01-09

    Hospira Recalls Plum A+ Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 297,833 Plum A+ infusion pumps because a door roller assembly may break, causing unrestricted flow or over-delivery of IV fluids.

    Product
    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792
    Category
    Distribution
    1 state