Events

Rappel de Device Recall Salivart Oral Moisturizer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Gebauer Company.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37150
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0497-2007
  • Date de mise en oeuvre de l'événement
    2007-01-19
  • Date de publication de l'événement
    2007-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49985
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Oral Moisturizer - Product Code LFD
  • Cause
    Microbial contamination-certain lots of product failed usp <61> microbial limits testing for total aerobic count during 6 month stability testing.
  • Action
    The recalling firm sent recall letters dated 1/23/2007 to their Distributor Customers and Non-distributor customers who received Salivart product from Lot Code: 06AA003. both letters include an attached recall response form which the customers are instructed to destroy the product, complete a form and fax back it to the recalling firm. The response forms provide verification that the form has been received by the customer(s). With the initiation of the RECALL EXPANSION for more lot codes to be recalled on 2/14/2007, the firm issued new recall letters dated, 2/13/2007, 2/15/2007 and 2/22/2007. These four letters provide the same basic information and also have attached recall response cards, however, they list the additional 6 lot codes subject to recall. The firm issued a Press Release concerning this recall through Cleveland (Business Wire) on 3/1/2007.

Device

Device Recall Salivart Oral Moisturizer
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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
    Gebauer Company

Manufacturer

Gebauer Company
  • Adresse du fabricant
    Gebauer Company, 4444 E 153rd St, Cleveland OH 44128
  • Source
    USFDA