Events

Recall of Gebauer"s Topical anesthetic skin refrigerant

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
    37778
  • Event Risk Class
    Class 2
  • Event Number
    Z-1062-2007
  • Event Initiated Date
    2007-04-17
  • Event Date Posted
    2007-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51529
  • 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 anesthetic skin refrigerant - Product Code MLY
  • Reason
    Mold contamination.
  • Action
    The firm sent a recall letter dated April 17, 2007 to all customers.

Device

Gebauer"s Topical anesthetic skin refrigerant
  • Model / Serial
    Lot number 9253 expires 11-08
  • Product Classification
    Physical Medicine Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.-(Product Number-0386-0008-01)
  • Manufacturer
    Gebauer Company

Manufacturer

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