Events

Rappel de Heated Ventilator Circuit

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 Teleflex Medical.

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
    72731
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0419-2016
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • Date de publication de l'événement
    2015-12-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142044
  • 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
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Cause
    Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
  • Action
    Teleflex sent an "Urgent Medical Device Recall Notification" dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this voluntary recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Heated Ventilator Circuit
  • Modèle / numéro de série
    Lot Numbers : 02K1300128 and 02L1302324
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.
  • Description du dispositif
    Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA