Events

Rappel de Device Recall AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, NonHeated

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 Carefusion 2200 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
    61943
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1900-2012
  • Date de mise en oeuvre de l'événement
    2012-05-29
  • Date de publication de l'événement
    2012-06-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109600
  • 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
    Heater, breathing system w/wo controller (not humidifier or nebulizer - Product Code BZE
  • Cause
    The y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. this leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
  • Action
    The firm, CareFusion, sent an "URGENT RECALL NOTICE" dated May 29, 2012 to all of the affected customers on the same date via registered return receipt mail. The notice described the product, problem and actions to be taken. The customers were instructed to immediately destroy any affected product in-stock at their facility and to NOT further distribute these products. NOTE: The notice stated "Carefusion is removing from the the market all lot numbers less than lot #0000414257 or begin with the letter 'Y' for all Infant Breathing Circuit product codes listed in the provided attachment". The customers were also instructed to not return the product to Carefusion. Return the product directly to: Owens and Minor Health Care Logistics at 1651 California Street, Suite C, Redlands, CA 92374, Attn: Recall Coordinator, for immediate replacement. NOTE: The notice the stated "Failure to follow these important measures may result in a potential patient safety risk". In addition, the customers were instructed to forward the recall notice to any customers to whom these products were sold, notifying them of the potential risk, advising them to discard or return any CareFusion AirLife Infant Breathing Circuits with the noted product/lot numbers for replacement; and to complete and return a enclosed reply form indicating the amount of inventory in stock, amount destroyed and amount returned. The distributors were requested to complete and return the attached Acknowledgement Form indicating that they have received the recall notice and that they communicated the Recall Notice to all customers who have purchased the affected breathing circuits via Fax to (847) 473-7774 or email to David.Wehrheim@Carefusion.com. They were also instructed to contact CareFusion Channel Management at (866) 802-6320 for further details on return and/or replacement of stock. If you have any questions related to this information, please call (847) 473-7495 or email David.Wehrheim@Caref

Device

Device Recall AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, NonHeated
  • Modèle / numéro de série
    product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
  • Description du dispositif
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico || Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Adresse du fabricant
    Carefusion 2200 Inc, 1500 Waukegan Rd, Mpwm Bldg., McGaw Park IL 60085-6728
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA