Events

Rappel de Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set

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
    57572
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0936-2011
  • Date de mise en oeuvre de l'événement
    2010-12-20
  • Date de publication de l'événement
    2011-01-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96674
  • 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
    Packaging may have been compromised, and sterility of product cannot be guaranteed.
  • Action
    The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an "Urgent Field Safety Notice" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer. If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: Jody.Cadd@teleflexmedical.com.

Device

Device Recall Arrow Super ArrowFlex(R) Percutaneous Sheath Introducer Set
  • Modèle / numéro de série
    Part No: CL-07645, Lot No: CF0014630
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.
  • Description du dispositif
    Super Arrow-Flex(R) PSI Set || Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures
  • 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