Events

Rappel de Device Recall PremierEdge MICROSURGICAL KNIFE 3.5mm Implant Knife

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 Oasis Medical Inc.

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
    45870
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0502-2008
  • Date de mise en oeuvre de l'événement
    2007-07-18
  • Date de publication de l'événement
    2008-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66351
  • 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
    Ophthalmic Knife - Product Code HNN
  • Cause
    Sterility (package integrity) compromised: the device is puncturing the packing during handling. once the packaging is damaged, the product is no longer sterile as labeled. this is an expansion of a previous recall.
  • Action
    A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.

Device

Device Recall PremierEdge MICROSURGICAL KNIFE 3.5mm Implant Knife
  • Modèle / numéro de série
    Lot No: DK0107V, DK0207E and DK0507V
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia
  • Description du dispositif
    PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF: PE 3435, OASIS Glendora, CA 91741
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Adresse du fabricant
    Oasis Medical Inc, 514 S Vermont Ave Bldg 510-528, Glendora CA 91741-6205
  • Société-mère du fabricant (2017)
    Oasis Medical Inc.
  • Source
    USFDA