Events

Rappel de Device Recall NeoPICC 1.9 FR 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 Arrow International 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
    30528
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0349-05
  • Date de mise en oeuvre de l'événement
    2004-11-24
  • Date de publication de l'événement
    2005-01-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-06-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36060
  • 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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Cause
    Complaints of vessel erosion when using this product.
  • Action
    The recalling firm issued a letter dated 11/23/04 to physicians informing them of the increase in complaints for vessel erosion and one death (at that time). On 12/3/04, the recalling firm issued a press release to alert the medical community of the problem and the need to return the device. The recalling firm issued a recall letter dated 12/7/04, to the Director of Purchasing, informing them of the adverse events associated with the use of the product and the need to return all of their inventory.

Device

Device Recall NeoPICC 1.9 FR Catheter
  • Modèle / numéro de série
    All lots higher than number 3231
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    The products were shipped to through specialty dealers/distributors to medical facilities nationwide. The product is also sold to government accounts and sales representatives. The product is also sold in Taiwan, Brazil, Hong Kong, Africia, and Canada.
  • Description du dispositif
    NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA