Events

Recall of Device Recall Volumetric Infusion Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Walkmed Infusion LLC.

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
    56750
  • Event Risk Class
    Class 1
  • Event Number
    Z-0307-2011
  • Event Initiated Date
    2010-06-17
  • Event Date Posted
    2010-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94445
  • 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
    Infusion Pump - Product Code FRN
  • Reason
    Pump door may be in a near shut position, but unlatched, and the "door open" alarm may not sound.
  • Action
    All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.

Device

Device Recall Volumetric Infusion Pump
  • Model / Serial
    Serial numbers: 1 thru 500, TR1041 through TR2559.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, CA, FL, and PA.
  • Product Description
    WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. || Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.
  • Manufacturer
    Walkmed Infusion LLC

Manufacturer

Walkmed Infusion LLC
  • Manufacturer Address
    Walkmed Infusion LLC, 96 Inverness Dr E Ste N, Centennial CO 80112-5311
  • Manufacturer Parent Company (2017)
    Walkmed Infusion LLC
  • Source
    USFDA