Events

Recall of Ferno Model 35X PROFlexX Ambulance Stretcher

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ferno-Washington 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
    49500
  • Event Risk Class
    Class 2
  • Event Number
    Z-2465-2008
  • Event Initiated Date
    2008-09-03
  • Event Date Posted
    2008-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73639
  • 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
    Stretcher - Product Code FPO
  • Reason
    The ferno model 35-x proflexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation.
  • Action
    On 9-03-2008 the firm sent via certified mail Urgent Voluntary Correction letters to their customers instructing them to immediately inspect the stretcher according to the 35X PROFlexx¿ Leg Inspections instruction sheet. Customers are to also telephone the firm upon completion of the inspection to arrange for a replacement kit. Contact Ferno Technical Support at 1-866-987-3776 for assistance.

Device

Ferno Model 35X PROFlexX Ambulance Stretcher
  • Model / Serial
    Serial Numbers Range between 06-002156 and 07-054091.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY,OH, OK, PA, SC, TN, TX, VA, WI, and WV, and countries of Austria, China, Egypt, Germany, Hong Kong, Japan, Lebanon, Mexico, Poland, United Kingdom, and South Africa.
  • Product Description
    Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • Manufacturer Address
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177
  • Manufacturer Parent Company (2017)
    Ferno-Washington Inc.
  • Source
    USFDA