Events

Rappel de Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) 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
    57218
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0898-2011
  • Date de mise en oeuvre de l'événement
    2010-11-09
  • Date de publication de l'événement
    2011-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95621
  • 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
    Percutaneous Catheter - Product Code DQY
  • Cause
    One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number cv-15703, but a double-lumen catheter with part number cv-16702 was actually packaged in the kit.
  • Action
    The recalling firm issued Urgent Medical Recall letters dated 11/9/10 to inform their customers of the problem and the need to return any unused product. Customers are to check their stock for the affected product, contact Arrow Customer Service for a Return Authorization Number, and complete the enclosed Recall Acknowledgement & Stock Status Form. For customers with no affected product in stock, the form should still be completed and also faxed to Arrow Customer Service. Affected product should be returned along with the original completed form to Arrow International, Inc. Arrow will replace the affected product once it has been returned. Additional information or clarification can be obtained from Arrow Customer Service at 1-919-361-3964.

Device

Device Recall ArrowHowes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R...
  • Modèle / numéro de série
    Lot/Serial Number: CF9065974.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Distribution Only -- Argentina and Columbia.
  • Description du dispositif
    Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter. Catalog #: CV-15703. || Permits venous access to the central circulation.
  • Manufacturer
    Arrow International Inc

Manufacturer

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