The Recall Desk

FDA (Devices) recall action 63990

Hospira Inc. recalled 2 products on 2016-07-06

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
2016-07-06
Critical
0
Units
35,596

Why these products were recalled

Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace 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.

1–2 of 2

  • HighFDA (Devices)··2016-07-06

    Hospira Symbiq Infusion Pumps Recalled for False Occlusion Alarms

    Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient therapy.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-07-06

    Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms

    Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration;
    Category
    Distribution
    0 states