Events

Recall of Device Recall Salivart Oral Moisturizer

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
    37150
  • Event Risk Class
    Class 2
  • Event Number
    Z-0497-2007
  • Event Initiated Date
    2007-01-19
  • Event Date Posted
    2007-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49985
  • 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
    Oral Moisturizer - Product Code LFD
  • Reason
    Microbial contamination-certain lots of product failed usp <61> microbial limits testing for total aerobic count during 6 month stability testing.
  • Action
    The recalling firm sent recall letters dated 1/23/2007 to their Distributor Customers and Non-distributor customers who received Salivart product from Lot Code: 06AA003. both letters include an attached recall response form which the customers are instructed to destroy the product, complete a form and fax back it to the recalling firm. The response forms provide verification that the form has been received by the customer(s). With the initiation of the RECALL EXPANSION for more lot codes to be recalled on 2/14/2007, the firm issued new recall letters dated, 2/13/2007, 2/15/2007 and 2/22/2007. These four letters provide the same basic information and also have attached recall response cards, however, they list the additional 6 lot codes subject to recall. The firm issued a Press Release concerning this recall through Cleveland (Business Wire) on 3/1/2007.

Device

Device Recall Salivart Oral Moisturizer
  • Model / Serial
    Lot ''06AA003'', expiration date 06/08 Lot ''06AA001'', expiration date 06/08 Lot ''06AA002'', expiration date 06/08 Lot ''06AA004'', expiration date 07/08 Lot ''06AA005'', expiration date 07/08 Lot ''06AA006'', expiration date 10/08 Lot ''06AA007'', expiration date 10/08
  • Product Classification
    Dental Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and medical facilities) and full size samples of product were given away at trade shows to medical, and dental offices and some end users consumers). A total of 240 units of product derived from Lot Code: 06AA001, were distributed to a single Canadian distributor under the assigned Lot Code: 06BB002
  • Product Description
    Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio
  • Manufacturer
    Gebauer Company

Manufacturer

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