Device Recall Salivart Oral Moisturizer

  • Modelo / Serial
    Lot ''06AA003'', expiration date 06/08 Lot ''06AA001'', expiration date 06/08 Lot ''06AA002'', expiration date 06/08 Lot ''06AA004'', expiration date 07/08 Lot ''06AA005'', expiration date 07/08 Lot ''06AA006'', expiration date 10/08 Lot ''06AA007'', expiration date 10/08
  • Clasificación del producto
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and medical facilities) and full size samples of product were given away at trade shows to medical, and dental offices and some end users consumers). A total of 240 units of product derived from Lot Code: 06AA001, were distributed to a single Canadian distributor under the assigned Lot Code: 06BB002
  • Descripción del producto
    Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Gebauer Company, 4444 E 153rd St, Cleveland OH 44128
  • Source
    USFDA