Recall of Stackhouse FreedomAire Lens/Hood

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by VIASYS Med Systems.

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
    33407
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-06
  • Event Initiated Date
    2005-09-13
  • Event Date Posted
    2005-10-04
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2005-12-30
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Hood, Surgical - Product Code FXY
  • Reason
    The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
  • Action
    VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.

Device

  • Model / Serial
    Part #10450, Catalog # SA-500/US, lot number 16963
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Japan, Chile and Switzerland
  • Product Description
    Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
  • Manufacturer

Manufacturer

  • Manufacturer Address
    VIASYS Med Systems, 100 Chaddick Dr, Wheeling IL 60090-6006
  • Source
    USFDA