Events

Recall of FluroEthyl.

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

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
    49463
  • Event Risk Class
    Class 2
  • Event Number
    Z-0218-2009
  • Event Initiated Date
    2008-09-03
  • Event Date Posted
    2008-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73484
  • 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
    Topical (vapocoolant) refrigerant. - Product Code MLY
  • Reason
    Some units of fluro-ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. the product can also leak coolant from the side of the valve onto the fingers of the user.
  • Action
    A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers. The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company. The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company. For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.

Device

FluroEthyl.
  • Model / Serial
    Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
  • Manufacturer
    Gebauer Company

Manufacturer

Gebauer Company
  • Manufacturer Address
    Gebauer Company, 4444 E 153rd St, Cleveland OH 44128
  • Source
    USFDA