Events

Recall of Device Recall Ferno PROFlexx Model 28Z Chair Cot

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
    76765
  • Event Risk Class
    Class 2
  • Event Number
    Z-1827-2017
  • Event Initiated Date
    2017-03-08
  • Event Date Posted
    2017-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154113
  • 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 recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
  • Action
    Consignees were contacted via telephone and email on 3/8/17. No product will be returned to the recalling firm. The firm and its service company will correct each product in the field at the customers location.

Device

Device Recall Ferno PROFlexx Model 28Z Chair Cot
  • Model / Serial
    17E003185, 17E003169, 17E003179, 17E003180, 17E003181, 17E003183, 17E003187, 17E003152, 17E003168, 17E003171, 17E003172, 17E003173, 17E003184, 17E003170, 17E003138, 17E003139, 17E003140, 17E003141, 17E003153, 17E003154, 17E003155, 17E003156, 17E003157, 17E003158, 17E003159, 17E003160, 17E003161, 17E003162, 17E003163, 17E003164, 17E003165, 17E003166, 17E003167, 17E003174
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. The recalled products were distributed to the following states: CA, FL, HI, IL, NY, OH. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. The recalled product was distributed to the following countries: Taiwan, United Arab Emirates, Thailand, Singapore
  • Product Description
    Ferno PROFlexx¿ Model 28Z Chair Cot
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • Manufacturer Address
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • Manufacturer Parent Company (2017)
    Ferno-Washington Inc.
  • Source
    USFDA