Events

Rappel de Device Recall Crosser 14S Catheter

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 Flowcardia 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
    50791
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0938-2011
  • Date de mise en oeuvre de l'événement
    2009-01-09
  • Date de publication de l'événement
    2011-01-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77308
  • 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
    Mislabeled expiration date: some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.
  • Action
    The firm, FlowCardia, Inc., sent an "URGENT! Medical Device Recall" letter dated January 9, 2009 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to return the product to FlowCardia, at the firms expense, for replacement and Confirm that this product has been used by completing and returning the attached fax document via fax to 408-616-0053. The customers were ask to please make an attempt to contact the customer service representatives, Operations specialist at 888-456-7286 or Vice President, Clinical, Quality & Regulatory Affairs at 408-617-0352 x302, within the next 30 days. Note: FlowCardia Sales, Clinical and Customer support will send notification via certified mail or traceable courier and track response. If you have any questions or need any additional information email (dmichaels@flowcardia.com) or telephone at 408-617-0352 x302. Alternatively you may contact customer service at 888-456-7286.

Device

Device Recall Crosser 14S Catheter
  • Modèle / numéro de série
    labeled shelf life code 2011-12, lot number 5053
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.
  • Description du dispositif
    Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA || Intended use: Catheter for use in surgery.
  • Manufacturer
    Flowcardia Inc.

Manufacturer

Flowcardia Inc.
  • Adresse du fabricant
    Flowcardia Inc., 745 N Pastoria Ave, Sunnyvale CA 94085-2918
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA