Events

Recall of Device Recall Prometra II Programmable Infusion Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Flowonix Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77442
  • Event Risk Class
    Class 2
  • Event Number
    Z-2740-2017
  • Event Initiated Date
    2017-05-22
  • Event Date Posted
    2017-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156065
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    Flowonix medical received a report of a patient implanted with the prometra ii programmable pump who may have received a fatal drug overdose during an mri procedure. the prometra ii pump has an fda-approved design feature intended to permit safe exposure to an mri without removing drug from the reservoir.
  • Action
    Flowonix sent an URGENT MEDICAL DEVICE CORRECTION Letter and Response Forms dated May 22, 2017, with updated instructions were sent via UPS 2nd Day Air on May 25, 2017 to healthcare professionals: physicians and MRI facilities and technicians. The documents will also be available at www.flowonix.com. A Correction Letter will also be sent to patients to inform them of the labeling changes. For further questions, please call (973) 426-9229.

Device

Device Recall Prometra II Programmable Infusion Pump
  • Model / Serial
    All
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    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).
  • Manufacturer
    Flowonix Medical, Inc.

Manufacturer

Flowonix Medical, Inc.
  • Manufacturer Address
    Flowonix Medical, Inc., 500 International Dr Ste 200, Mount Olive NJ 07828-1381
  • Manufacturer Parent Company (2017)
    Flowonix Medical Inc.
  • Source
    USFDA