The Recall Desk

FDA (Devices) recall action 64005

Hospira Inc. recalled 2 products on 2016-11-16

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
2016-11-16
Critical
0
Units
21,234

Why these products were recalled

May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of 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.

1–2 of 2

  • HighFDA (Devices)··2016-11-16

    Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown

    Hospira is recalling Symbiq Two Channel Infusers that may display a white screen, causing the device to stop infusion and sound an alarm, which can delay or interrupt therapy.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-11-16

    Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown

    Hospira is recalling 10,337 Symbiq One Channel Infusers because a software issue may cause a white screen, stopping infusion and interrupting therapy.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents…
    Category
    Distribution
    0 states