Events

Rappel de Device Recall Arrow International, Inc. 7FR 3Lumen Arrowgard Blue Plus(R) Pressure Injectable Central Venous Cat

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
    62125
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1823-2012
  • Date de mise en oeuvre de l'événement
    2012-06-07
  • Date de publication de l'événement
    2012-06-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109883
  • 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 intravascular therapeutic short - term less than 30 days - Product Code FOZ
  • Cause
    Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
  • Action
    Arrow International sent a Urgent Medical Device Recall Notification letter dated June 11, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot numbers listed. 2. To return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of the product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization ( RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete t he enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.

Device

Device Recall Arrow International, Inc. 7FR 3Lumen Arrowgard Blue Plus(R) Pressure Injectable Ce...
  • Modèle / numéro de série
    Lot number RF2033361
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
  • Description du dispositif
    Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A || The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
  • 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