Events

Rappel de 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
    79196
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1171-2018
  • Date de mise en oeuvre de l'événement
    2017-09-22
  • Date de publication de l'événement
    2018-03-01
  • 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=162626
  • 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 bypass - Product Code DTN
  • Cause
    The device is used as part of extracorporeal membrane oxygenation (ecmo) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
  • Action
    The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to ytamari@cirtec.com as soon as possible.

Device

BetterBladder
  • Modèle / numéro de série
    **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • Description du dispositif
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

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