Events

Rappel de Device Recall Bigger BetterBladder

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 Circulatory Technology 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
    55137
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1323-2010
  • Date de mise en oeuvre de l'événement
    2009-06-03
  • Date de publication de l'événement
    2010-04-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90000
  • 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
    reservoir, blood, cardiopulmonary - Product Code DTN
  • Cause
    During an fda inspection, it was discovered that the firm had conducted a silent recall of its bigger better bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.
  • Action
    The firm, Circulatory Technology, Inc., sent an email to Bigger Better-Bladder end user accounts on 6/03/09 and again on 6/13/09. The firm followed up with phone calls to the user customers. The emails and calls discussed the product, problem and the actions to be taken by the customers. The customers are ask to examine their stock of Bigger Better-Bladder for the affected units and then visually examine each unit to assure that adhesive has been applied and when the tube is bent away from cap, no separation is visible along the joint between the two according to the picture provided. The customers should return for full credit or a replacement of any product that has a separation of the seal. Please feel free to contact Mr. Yehuda Tamari at 516-624-2424 with any questions.

Device

Device Recall Bigger BetterBladder
  • Modèle / numéro de série
    Lot Number 9910-18907 (exp. 10/2011)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
  • Description du dispositif
    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

Circulatory Technology Inc
  • Adresse du fabricant
    Circulatory Technology Inc, 21 Singworth Street, Oyster Bay NY 11771-3703
  • Société-mère du fabricant (2017)
    Circulatory Technology Inc
  • Source
    USFDA