The Recall Desk

FDA (Devices) recall action 63518

Hospira Inc. recalled 3 products on 2012-12-19

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
2012-12-19
Critical
0
Units
—

Why these products were recalled

The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.

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

States named across these recalls

1–3 of 3

  • LowFDA (Devices)··2012-12-19

    Hospira Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob

    Hospira is recalling Plum A+ Hyperbaric Infusion Pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-program
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-12-19

    Hospira Recalls Plum A+ Infusion Pumps Due to Volume Knob Defect

    Hospira is recalling Plum A+ infusion pumps because the volume control knob may reverse the alarm volume direction.

    Product
    Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming f
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-12-19

    Hospira Recalls Plum A+ Infusion Pumps Due to Reversed Volume Knob

    Hospira is recalling Plum A+ single channel infusion pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.

    Product
    Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12
    Category
    Distribution
    1 state