Class 3 Device Recall Salvart Oral Moisturizer

• Date Initiated by Firm: February 23, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 11, 2012
• Recall Number: Z-0641-04
• Recall Event ID: 28415
• 510(K)Number: k981693
• Product Classification: Saliva, Artificial - Product Code LFD
• Product: Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
• Code Information: Lots: #031751F09, #031761F10, #031771F11. Expiration date for all lots: June 2005.
• Recalling Firm/ Manufacturer: Gebauer Co; 9410 Saint Catherine Ave; Cleveland OH 44104-5526
• For Additional Information Contact: 216-271-5252
• Manufacturer Reason for Recall: The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.
• FDA Determined Cause: Other
• Action: The firm contacted the affected consignees by letter on 2/23/2004. The product is to be returned.
• Quantity in Commerce: 25,561 cans
• Distribution: The product was shipped to consignees located nationwide.
• 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.