Events

Rappel de Device Recall Femoral Arterial Line Catheterization Kit

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
    74489
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2202-2016
  • Date de mise en oeuvre de l'événement
    2016-06-02
  • Date de publication de l'événement
    2016-07-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147776
  • 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
    Wire, guide, catheter - Product Code DQX
  • Cause
    Labeling error. some shipping cartons labeled as ask-04018-vuh contained ask-04020-vuh kits; and some shipping cartons labeled as ask-04020-vuh contained ask-04018-vuh kits.
  • Action
    Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Femoral Arterial Line Catheterization Kit
  • Modèle / numéro de série
    Lot/Batch Numbers: 23F14M0829, 23F14M0986
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution in the states of TN and KY.
  • Description du dispositif
    Femoral Arterial Line || Catheterization Kit with Sharps Safety Features || 510K 810675, product code DQX, Device Listing D025180 || Material ASK-04018-VUH || Product Usage: || The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
  • 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