Events

Recall of Device Recall PROFlex Transporter, model 35PST.

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
    34010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0201-06
  • Event Initiated Date
    2003-03-28
  • Event Date Posted
    2005-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42904
  • 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 firm received complaints of the stretchers folding. a fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.
  • Action
    The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.

Device

Device Recall PROFlex Transporter, model 35PST.
  • Model / Serial
    All stretchers containing a serial number beginning with the letter ''L'' and followed by a sequence of six numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide to 27 states: TN, MA, VT, IL, KY, NY, SC, WI, TX, MO, NH, CO, GA, NC, CA, VA, IA, PA, CT, OH, NJ, ID, WV, AL, AR, ME and IN.
  • Product Description
    PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.
  • 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