Events

Recall of Device Recall Salvart Oral Moisturizer

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

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
    28415
  • Event Risk Class
    Class 3
  • Event Number
    Z-0641-04
  • Event Initiated Date
    2004-02-23
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31803
  • 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
    Saliva, Artificial - Product Code LFD
  • Reason
    The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.
  • Action
    The firm contacted the affected consignees by letter on 2/23/2004. The product is to be returned.

Device

Device Recall Salvart Oral Moisturizer
  • Model / Serial
    Lots: #031751F09, #031761F10, #031771F11. Expiration date for all lots: June 2005.
  • Product Classification
    Dental Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    The product was shipped to consignees located nationwide.
  • Product Description
    Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
  • Manufacturer
    Gebauer Co

Manufacturer

Gebauer Co
  • Manufacturer Address
    Gebauer Co, 9410 Saint Catherine Ave, Cleveland OH 44104-5526
  • Source
    USFDA