Events

Rappel de Device Recall BBB3872

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
    74991
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2832-2016
  • Date de mise en oeuvre de l'événement
    2016-07-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149041
  • 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 seal between the balloon and the housing may leak.
  • Action
    The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to ytamari@cirtec.com. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.

Device

Device Recall BBB3872
  • Modèle / numéro de série
    Lot # 014648 USE BY: 09/01/2018
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: LA, MI, NY, OH, OR & TX.
  • Description du dispositif
    The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 || A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • 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