Events

Rappel de Device Recall Hudson RCI One Way Valve

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 Telefelx 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
    53960
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0652-2010
  • Date de mise en oeuvre de l'événement
    2009-12-02
  • Date de publication de l'événement
    2010-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-08-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86949
  • 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
    Airway connector (Extension) - Product Code BZA
  • Cause
    Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. each of these valves demonstrate the appropriate direction with a red arrow. the reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665. if the red arrows are not followed, the valve may be placed in the circuit in the wrong.
  • Action
    Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained. Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990

Device

Device Recall Hudson RCI One Way Valve
  • Modèle / numéro de série
    Catalog number: 1665, Lot number: 02J0901967
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    CA, IL, NE, NJ, TX, VA, WI and Canada.
  • Description du dispositif
    Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Adresse du fabricant
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA