Events

Rappel de AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES

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 Encision, 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
    55286
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1543-2010
  • Date de mise en oeuvre de l'événement
    2010-04-05
  • Date de publication de l'événement
    2010-05-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90483
  • 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
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Electrosurgical electrode tip insulation may crack and break off during use.
  • Action
    A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.

Device

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
  • Modèle / numéro de série
    Lot No.: PK
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.
  • Description du dispositif
    AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. || Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Adresse du fabricant
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Société-mère du fabricant (2017)
    Encision, Inc.
  • Source
    USFDA