Class 2 Device Recall Salivart Oral Moisturizer

• Date Initiated by Firm: January 19, 2007
• Date Posted: March 20, 2007
• Recall Status: Terminated on December 17, 2007
• Recall Number: Z-0497-2007
• Recall Event ID: 37150
• 510(K)Number: K981693
• Product Classification: Oral Moisturizer - Product Code LFD
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Gebauer Company; 4444 E 153rd St; Cleveland OH 44128
• For Additional Information Contact: Amy Paukovits; 216-581-3030 Ext. 120
• Manufacturer Reason for Recall: Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 34,545 cans
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFD and Original Applicant = GEBAUER CO.