Z-0641-04

Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer...

Name: Z-0641-04 Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer...
Creator: Gebauer Co
Published: 2004-02-23
License: https://open.fda.gov/license/

Gebauer Co / initiated 2004-02-23 / Terminated

FDA source

Gebauer Co began a recall of Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH on 2004-02-23. The reason FDA records is "The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0641-04
Status: Terminated
Initiated: 2004-02-23
Posted: 2004-07-20
Terminated: 2012-04-11
Recalling firm: Gebauer Co
Product: Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
Product code: LFD Saliva, Artificial
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 root 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.
Product codes and lots: Lots: #031751F09, #031761F10, #031771F11. Expiration date for all lots: June 2005.

Product code LFD

K981693UnclassifiedSalivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25Gebauer Co. / cleared 2001-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)