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    Prometra Clinician Programmer Print Tool

    FDA UDI
    Flowonix Medical, Inc.·00810335020266·Prometra Clinician Programmer Print Tool

    Prometra Programmer

    FDA UDI
    Flowonix Medical, Inc.·00810335020129·The Prometra Programmer is a non-sterile handhe...

    Prometra Refill Kit

    FDA UDI
    Flowonix Medical, Inc.·00810335020143·The Refill Kit is sterile and provides the comp...

    Prometra Programmable Pump

    FDA UDI
    Flowonix Medical, Inc.·00810335020082·The Prometra Programmable Pump is a sterile, ba...

    Prometra Physician Configuration Device

    FDA UDI
    Flowonix Medical, Inc.·00810335020181·The Physician Configuration Device is used to c...

    Prometra Tunneler

    FDA UDI
    Flowonix Medical, Inc.·00810335020150·The Tunneler is used for subcutaneous placement...

    Prometra Intrathecal Catheter

    FDA UDI
    Flowonix Medical, Inc.·00810335020099·The Intrathecal Catheter is a sterile, single-p...

    Prometra Clinical Programmer

    FDA UDI
    Flowonix Medical, Inc.·00810335020549·Prometra Clinician Prgrammer

    Prometra Programmer

    FDA UDI
    Flowonix Medical, Inc.·00810335020167·The Prometra Programmer is a non-sterile handhe...

    Prometra II Pump

    FDA UDI
    Flowonix Medical, Inc.·00810335020228·The Prometra II Programmable Pump is a sterile,...

    Prometra Catheter Revision Kit

    FDA UDI
    Flowonix Medical, Inc.·00810335020105·The Catheter Revision Kit is a sterile kit desi...

    Prometra Patient Therapy Controller

    FDA UDI
    Flowonix Medical, Inc.·00810335020174·The Patient Therapy Controller (PTC) is a handh...

    Prometra Catheter Access Kit

    FDA UDI
    Flowonix Medical, Inc.·00810335020136·The Catheter Access Kit is sterile and provides...

    Prometra Programmable Pump

    FDA UDI
    Flowonix Medical, Inc.·00810335020242·Prometra II 40ml Programmable Pump

    FLOWONIX PROMETRA II

    FDA Adverse Event
    Injury ·FLOWONIX MEDICAL INC.·Product code LKK·May 24, 2023

    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 revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

    FDA Enforcement
    Class II ·Terminated·Flowonix Medical, Inc.·July 26, 2017

    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 revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

    FDA Recall
    Terminated ·Flowonix Medical, Inc.·Product code LKK·May 22, 2017

    PROMETRA PROGRAMMABLE PUMP

    FDA Adverse Event
    Injury ·FLOWONIX MEDICAL, INC·Product code LKK·October 19, 2016

    PROMETRA PROGRAMMABLE PUMP

    FDA Adverse Event
    Malfunction ·FLOWONIX MEDICAL, INC·Product code LKK·November 23, 2016

    PROMETRA II PROGRAMMABLE PUMP

    FDA Adverse Event
    Death ·FLOWONIX MEDICAL, INC·Product code LKK·November 16, 2016