FDA Medical Device Recalls (openFDA)
Gebauer Co: Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
- Recall number
- Z-0641-04
- 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.
- Status
- Terminated
- Initiated
- 2004-02-23
- Posted
- 2004-07-20
- Terminated
- 2012-04-11
- Reason
- The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.
- Root cause
- Other
- Action
- The firm contacted the affected consignees by letter on 2/23/2004. The product is to be returned.
- Quantity
- 25,561 cans
- Distribution
- The product was shipped to consignees located nationwide.
- Lot, serial or model codes
- Lots: #031751F09, #031761F10, #031771F11. Expiration date for all lots: June 2005.
- 510(k) numbers
- ["K981693"]
- PMA numbers
- not on file
- Product code
- LFD
- Firm FEI
- 1519179
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28