Events

Rappel de Arrow MultiLumen Central Venous Catheterization

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
    69290
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0076-2015
  • Date de mise en oeuvre de l'événement
    2014-09-18
  • Date de publication de l'événement
    2014-10-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130176
  • 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, percutaneous - Product Code DQY
  • Cause
    Arrow international, inc. has initiated a voluntary recall for product code ak- 12703, lot number rf3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. all kits packaged within the corrugate are correctly labeled. there is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.
  • Action
    Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken. Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. Arrow International, Inc. is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Arrow MultiLumen Central Venous Catheterization
  • Modèle / numéro de série
    Catolog No - AK-12703 lot number RF3039028
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
  • Description du dispositif
    Multi-Lumen Central Venous Catheterization || Kit
  • 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