Events

Rappel de BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only

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 C.R. Bard, 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
    75469
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0738-2017
  • Date de mise en oeuvre de l'événement
    2016-08-03
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150452
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Cause
    Package defect: products may be at risk for having a slit defect on the package and that may affect the product sterility.
  • Action
    BARD Medical sent an Urgent Medical Device Product Recall letter dated August 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine product subject to the recall. Complete and return the accompanying Recall & Effectiveness Check Form attached to the letter. If product was further distributed please identify those customers and notify them at once of the product recall by forwarding a copy of the letter. For questions regarding this recall call 770-784-6220.

Device

BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only
  • Modèle / numéro de série
    Product Code: 802065, Lot Numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494 and NGZF4014.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.
  • Description du dispositif
    BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Adresse du fabricant
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA