Events

Rappel de Device Recall Bard DispozABag

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., Urological Division.

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
    25894
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0732-03
  • Date de mise en oeuvre de l'événement
    2003-03-25
  • Date de publication de l'événement
    2003-04-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26681
  • 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
    Bag, Urine Collection, Leg, For External Use, Sterile - Product Code FAQ
  • Cause
    There is a potential for package seals to be open after sterilization.
  • Action
    The oldest lot that the firm has confirmed in inventory that had an open seal was manufactured in October 2002. Based upon depletion analysis with distributor inventory being three months and an additional assurance of 12 months, the firm is removing product manufactured from October 1, 2001 through February 28, 2003. Consignees were notified via certified letter with Business Reply Form attached for effectiveness check. Consignees were advised to remove/segregate, and return affected product for credit.

Device

Device Recall Bard DispozABag
  • Modèle / numéro de série
    Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
  • Description du dispositif
    Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • Adresse du fabricant
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
  • Source
    USFDA