Events

Rappel de Device Recall Dual Lumen Catheter

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 OriGen Biomedical, 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
    70988
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1456-2015
  • Date de mise en oeuvre de l'événement
    2015-03-30
  • Date de publication de l'événement
    2015-04-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135794
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Cause
    Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
  • Action
    The firm, OriGen, sent an "URGENT; MEDICAL DEVICE RECALL" letter dated 3/30/2015 and response form to all consignees via e-mail. The conisgnees were notified on 3/31/15 and 4/1/15. The recalling firm also posted a recall notification on the ELSO website, which is a public site mainly used by professionals within the ECMO community and press release dated 4/15/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to discontinue use of all OriGen W13F Reinforced Dual Lumen ECMO Catheters from the lot; immediately return any unused product to OriGen Biomedical; and complete and return the attached acknowledgement and receipt form even if you do not currently have product in your inventory. The firm recommends that the consignee use an alternate product in the interim. If you have any questions regarding the return of product that you have on hand or the status of the investigation, please do not hesitate to conact the company at: OriGen Biomedical, Attn: Director, Quality and Regulatory Affairs, 7000 Burleson Rd, Bldg D, Austin, TX 78744 or call +1 512 474 7278 CST Monday-Friday 8:00-5:00.

Device

Device Recall Dual Lumen Catheter
  • Modèle / numéro de série
    Lot N18549
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.
  • Description du dispositif
    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. || OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
  • Manufacturer
    OriGen Biomedical, Inc.

Manufacturer

OriGen Biomedical, Inc.
  • Adresse du fabricant
    OriGen Biomedical, Inc., 7000 Burleson Rd, Bldg D, Austin TX 78744-3202
  • Société-mère du fabricant (2017)
    Origen Biomedical Inc.
  • Source
    USFDA