The Recall Desk

FDA (Devices) recall action 82586

Flowonix Medical Inc recalled 5 products on 2019-06-12

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2019-06-12
Critical
0
Units
7,775

Why these products were recalled

The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.

The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.

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.

1–5 of 5

  • HighFDA (Devices)··2019-06-12

    Flowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns

    Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.

    Product
    Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-06-12

    Flowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns

    Flowonix Medical Inc is recalling Prometra Clinician Programmer software due to a defect that can cause intrathecal pumps to shut down unexpectedly.

    Product
    Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-06-12

    Flowonix Prometra II Pump Recall for Unexpected Shutdowns

    Flowonix Medical Inc is recalling 6,445 Prometra II Programmable Pumps because a software defect can cause the device to shut down unexpectedly.

    Product
    Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-06-12

    Flowonix Prometra II Pump Recall for Unexpected Shutdowns

    Flowonix Medical Inc. is recalling 163 Prometra II Programmable Pumps due to a software defect that can cause unexpected shutdowns.

    Product
    Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
    Category
    Distribution
    0 states