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U.S. Department of Health and Human Services

Class 3 Device Recall Salvart Oral Moisturizer

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 Class 3 Device Recall Salvart Oral Moisturizersee related information
Date Initiated by FirmFebruary 23, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 11, 2012
Recall NumberZ-0641-04
Recall Event ID 28415
510(K)NumberK981693 
Product Classification Saliva, Artificial - Product Code LFD
ProductSalvart 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.
FEI Number 1519179
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 2		Other
ActionThe firm contacted the affected consignees by letter on 2/23/2004. The product is to be returned.
Quantity in Commerce25,561 cans
DistributionThe product was shipped to consignees located nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LFD
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