Events

Rappel de Disposable Bimanual Irrigation and Aspiration Handpiece Set

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
    38120
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0741-2007
  • Date de mise en oeuvre de l'événement
    2007-04-09
  • Date de publication de l'événement
    2007-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53023
  • 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 irrigation and aspiration - Product Code KYG
  • Cause
    Plastic shavings are coming from the product handle during irrigation. use of this product may leave plastic shavings in the patient's eyes.
  • Action
    An April 9, 2007, notification of the recall will be sent to distributors and users. They are requested to notify down to the user (physician) level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by induding a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."

Device

Disposable Bimanual Irrigation and Aspiration Handpiece Set
  • Modèle / numéro de série
    ltem #1720 Bimanual Irrigation/Aspiration Set 20 Gauge: DB0105B, DB0l06A, DB0605F, DB0705J, DB0705J, DB0804B, DB0804B, DB1005A, DB1104H, DB1104I; Item #1720-A Disposable Bimanual Aspiration Handpiece 20g: DB1004I; ltem # 1720-I Disposable Bimanual Irrigation Handpiece 20g: DB0105D, DB0305A, DB0305A, DB0705B, DB0705I, DB1004H; Item #1720-S Disp Bimanual l/A Set 20g Dual Port Smooth: DB0505B, DB0505B, DB0605G, DB0705K, DB1205C
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, United Kingdom, Canada, Spain, Turkey, Kuwait, Colombia, Italy, Greece, Australia, Switzerland, South Africa, Germany, Portugal, and France.
  • Description du dispositif
    Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A - Disposable Bimanual Aspiration Handpiece 20g; Item #1720-I Disposable Bimanuals Irrigation/Aspiration Set 20g, Open End; Item #1720-S Disposable Bimanuals Irrigation/Aspiration Set, 20g, Dual Port, Smooth. For use in cataract surgical procedures.
  • Manufacturer
    Oasis Medical Inc

Manufacturer

Oasis Medical Inc
  • Adresse du fabricant
    Oasis Medical Inc, 510-528 South Vermont Ave, Glendora CA 91741
  • Source
    USFDA