Events

Rappel de Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port

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
    58331
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2048-2011
  • Date de mise en oeuvre de l'événement
    2011-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99000
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.
  • Action
    The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been received and applied the product can be released from quarantine. An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need. If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.

Device

Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Val...
  • Modèle / numéro de série
    Catalog # PH-09806 -- Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: PA and NJ.
  • Description du dispositif
    Percutaneous Sheath Introducer Kit || Intended usage: Permits venous access and catheter introduction to the central circulation system
  • 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