Events

Recall of Device Recall Ferno Model 35X PROFlexx Stretchers

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
    69978
  • Event Risk Class
    Class 2
  • Event Number
    Z-0995-2015
  • Event Initiated Date
    2014-12-03
  • Event Date Posted
    2015-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132060
  • 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, wheeled - Product Code FPO
  • Reason
    The wheel castor assemblies may be loosening on the stretchers.
  • Action
    Ferno initiated contact with customers via email and telephone on Wednesday, December 3, 2014. The firm will replace all wheel caster assemblies.

Device

Device Recall Ferno Model 35X PROFlexx Stretchers
  • Model / Serial
    The following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The affected product was distributed to the following states: OH, MA, HI, NJ, TN, TX, MO, and GA. The affected product was distributed to the following foreign countries: Canada, Germany and Venezuela.
  • Product Description
    Ferno Model 35X PROFlexx Stretchers, one unit per package
  • 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