The Recall Desk

FDA (Devices) recall action 63056

Hospira Inc. recalled 2 products on 2012-10-31

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
2012-10-31
Critical
0
Units
33,681

Why these products were recalled

The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.

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)··2012-10-31

    Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunctions

    Hospira is recalling Symbiq Two Channel Infusers because the touchscreen may fail to respond or register incorrect values, potentially causing medication delivery errors.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-10-31

    Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunction

    Hospira is recalling 19,614 Symbiq One Channel Infusion Pumps because the touchscreen may fail to respond or register incorrect values, potentially leading to medication dosing errors.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
    Category
    Distribution
    1 state