Recall Z-0641-04 ยท LFD Saliva, Artificial
Gebauer Co
Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH.
| Date | Jul 20, 2004 (initiated Feb 23, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 Gebauer Co., Aug 6, 2001 |