Events

Recall of Device Recall IVEA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Firefly 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
    75571
  • Event Risk Class
    Class 2
  • Event Number
    Z-0767-2017
  • Event Initiated Date
    2016-11-01
  • Event Date Posted
    2016-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150828
  • 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
    Stand, infusion - Product Code FOX
  • Reason
    The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
  • Action
    Firm notified customers on **11/18/16** via certified "Urgent: Medical Device Recall (Field Correction) IVEA Model 500A" letter to correct product in the field. Customers were asked to thoroughly read the letter and to immediately follow the actions in the enclosed Product Correction Kit. The instructions include steps for cleaning the correction area and installing the permanent adhesive caps, as well as, completing and returning the product correction form to Firefly Medical. Customers may continue to use their units until the Product Correction actions are complete, as long as pins are not protruding. If the pins are protruding, then customers are to stop using the device immediately and complete the product correction instructions. Customers can call 970-472-5323 or e-mail info@iveamobility.com if they have any questions.

Device

Device Recall IVEA
  • Model / Serial
    Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    IVEA 500A || Intended for Med-Surg patient care.
  • Manufacturer
    Firefly Medical, Inc.

Manufacturer

Firefly Medical, Inc.
  • Manufacturer Address
    Firefly Medical, Inc., 320 E Vine Dr Ste 312, Fort Collins CO 80524-2332
  • Manufacturer Parent Company (2017)
    Firefly Medical Inc.
  • Source
    USFDA