Events

Rappel de StatLock IV Premium Catheter Stabilization Device

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 Bard Access Systems 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
    77132
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2120-2017
  • Date de mise en oeuvre de l'événement
    2017-04-25
  • Date de publication de l'événement
    2017-05-19
  • 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=155010
  • 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
    Device, intravascular catheter securement - Product Code KMK
  • Cause
    Statlocktm iv premium catheter stabilization device may contain an incorrectly sized retainer clip.
  • Action
    Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.

Device

StatLock IV Premium Catheter Stabilization Device
  • Modèle / numéro de série
    Lot Number JUAQF675, Exp 2/28/2019
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
  • Description du dispositif
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
  • Manufacturer
    Bard Access Systems Inc.

Manufacturer

Bard Access Systems Inc.
  • Adresse du fabricant
    Bard Access Systems Inc., 605 N 5600 W, Salt Lake City UT 84116-3738
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA