Events

Recall of Device Recall Triton 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
    72331
  • Event Risk Class
    Class 2
  • Event Number
    Z-0242-2016
  • Event Initiated Date
    2015-10-01
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140640
  • 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 - Product Code FRN
  • Reason
    The device might fail to detect air in line while infusing the medication venofer. this may occur when a drop of venofer gets stuck in the tubing adjacent to the bubble detector and the total volume limit is programmed higher than the actual bag volume.
  • Action
    A Field Notification (letter) was provided to users on 10/01/15 to remind them of the following:use air elimination filters, as appropriate, not to over program into the device the volume to be infused, remove air from the IV bag prior to starting the infusion, issues associated with the use of Venofer or similar drugs. No products are being returned.

Device

Device Recall Triton Infusion Pump
  • Model / Serial
    Model numbers 300000, 400000
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.
  • Product Description
    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
  • Manufacturer
    WalkMed Infusion, LLC

Manufacturer

WalkMed Infusion, LLC
  • Manufacturer Address
    WalkMed Infusion, LLC, 6555 S Kenton St Ste 304, Englewood CO 80111-6838
  • Manufacturer Parent Company (2017)
    Walkmed Infusion LLC
  • Source
    USFDA