The Recall Desk

Manufacturer

Flowonix Medical, Inc.

13 recalls in our database name Flowonix Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
1
Severe
0
Most recent
2021-07-07

Of the 13 recalls from Flowonix Medical, Inc. we have scored against our rubric, 1 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

  • HighFDA (Devices)·Z-1996-2021·2021-07-07

    Infusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions

    Flowonix Medical is recalling physician order forms for Prometra infusion pumps due to ambiguous wording that could be misinterpreted as instructions to reuse previously extracted medication, posing an infection risk.

    Product
    Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling Prometra II 40mL implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms.

    Product
    Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2020·2020-02-19

    Flowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2020·2020-02-19

    Flowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2020·2020-02-19

    Flowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling US Clinical 20mL Programmable Pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra II 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms for valve system issues.

    Product
    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2019·2019-06-12

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2019·2019-06-12

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2019·2019-06-12

    Flowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns

    Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.

    Product
    Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2019·2019-06-12

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2019·2019-06-12

    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
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2740-2017·2017-07-26

    Flowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI

    Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.

    Product
    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revise
    Category
    Medical Device
    Distribution
    Distributed nationwide