Rappel de Device Recall Bovie Precise 360 Handpiece

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 Bovie Medical Corporation.

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
    74790
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2647-2016
  • Date de mise en oeuvre de l'événement
    2016-07-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
  • Action
    Consignees were notified by written recall notice sent via certified mail or courier on July 18, 2016 to quarantine their inventory of the Precise 360 Handpiece, identify and contact their customers that have received the affected product and provide the a copy of the attached field safety notice. Customers are requested to return affected product, and return all affected product currently in their possession. All customer inventory should be reviewed, discontinue use, and return all Bovie Precise 360 handpieces to: Quality Assurance Department, Bovie Medical Corporation, 5115 Ulmerton Road, Clearwater, Florida 33760, Attn: Precise 360 Recall. Also, please write the authorization number RMA XXXX on the outside of the shipping container and use UPS account number 342562 and return via ground shipping and Fax or email the attached recall return response form to the email or fax indicated on the form as soon as possible and include a copy with the shipment. A completed recall return response form is required even if the customer has no product to return. If you have any questions about this recall or the product affected by the recall, call 727-803-8617.

Device

  • Modèle / numéro de série
    Lot 0316D and 0516B.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
  • Description du dispositif
    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle || Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Bovie Medical Corporation, 5115 Ulmerton Rd, Clearwater FL 33760-4004
  • Société-mère du fabricant (2017)
  • Source
    USFDA