Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland
FDA device recall Z-0641-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Gebauer Co
- 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.
- Action taken
- The firm contacted the affected consignees by letter on 2/23/2004. The product is to be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFD
- Quantity affected
- 25,561 cans
- Distribution
- The product was shipped to consignees located nationwide.
- Date initiated
- 2004-02-23
- Date posted
- 2004-07-20
- Date terminated
- 2012-04-11
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 (K981693) | Gebauer Co. | 2001-08-06 |