Events

Rappel de Device Recall Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet

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 Peripheral Vascular 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
    35201
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0913-06
  • Date de mise en oeuvre de l'événement
    2006-05-01
  • Date de publication de l'événement
    2006-05-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45532
  • 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
    Biopsy Needle - Product Code FCG
  • Cause
    Manufacturing change that has introduced variability in the length of the inner stylet. when the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.
  • Action
    Recall letters were sent to all consignees (Radiology Department Manager with a copy to the Hospital Administrator) via Federal Express overnight delivery with signature receipt required on May 1, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV).

Device

Device Recall Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet
  • Modèle / numéro de série
    Lot # REP JO196
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed to the following five states: 1) California, 2) Florida 3) New Jersey, 3) Missouri, 4) Texas, 5) Washington. The product was also distributed to Canada and Latin America. Note: units distributed to Latin America remained in Bard''s distribution system and have been returned.
  • Description du dispositif
    Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. || The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Adresse du fabricant
    Bard Peripheral Vascular Inc, 1625 W 3rd St, Tempe AZ 85281-2438
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA