Events

Rappel de EndoVive One Step Button , Low profile Initial Placement PEG Kit

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 Boston Scientific Corp.

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
    72364
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0402-2016
  • Date de mise en oeuvre de l'événement
    2015-09-11
  • Date de publication de l'événement
    2015-12-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140781
  • 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
    Tube, gastro-enterostomy - Product Code KGC
  • Cause
    Boston scientific corp. initiated a voluntary recall of specific lots of the endovive one step button, including the decompression tube and low profile replacement button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the peg button.
  • Action
    Boston Scientific Corp. sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated September 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you identify any product from the affected lot within your inventory, please segregate the affected product immediately and return it to Boston Scientific in accordance with the enclosed recall instructions. You will receive replacements for all recalled product that is returned to Boston Scientific. If you are a distributor, or hospital please note that this recall is to the customer level. Please notify any customer who has received affected product. We are notifying affected worldwide regulatory authorities of this Recall Removal as required. Please read carefully through the enclosed Recall Removal Instructions. Your local Sales Representative can answer any questions that you may have regarding this Recall Removal. We regret any inconvenience that this action may cause, and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. We are committed to continuing to offer products that meet the highest quality standards that you expect from Boston Scientific. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to Boston Scientific by calling 1-866-868-4004.

Device

EndoVive One Step Button , Low profile Initial Placement PEG Kit
  • Modèle / numéro de série
    Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
  • Description du dispositif
    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Adresse du fabricant
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA