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Terminated

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

FDA Recall Z-0641-04 · Posted 2004-07-20

Recalling FirmGebauer Co
Recall StatusTerminated
Product CodeLFD
Date Initiated2004-02-23
Date Terminated2012-04-11
Product Quantity25,561 cans

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.

Firm Action

The firm contacted the affected consignees by letter on 2/23/2004. The product is to be returned.

Root Cause

Other

Distribution Pattern

The product was shipped to consignees located nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981693SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25Gebauer Co. · 2001-08-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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