Events

Rappel de Device Recall Sterile Sheridan/HVT Cuffed, Murphy Eye,

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
    74034
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1938-2016
  • Date de mise en oeuvre de l'événement
    2016-05-05
  • Date de publication de l'événement
    2016-06-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146015
  • 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
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Cause
    The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
  • Action
    The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated May 5, 2016 to its accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine product; communicate this recall to any of your customers who have received product; have your customers return to you any affected product with Recall Acknowledgement Form; contact Teleflex Medical Customer Service for more information at 1-866-246-6990; and complete and return Recall Acknowledgment Form via fax to 1-855-419-850, Attn: Customer Service or email to recalls@teleflex.com, even if you and your customers have no affected stock/product. Teleflex will provide you with instructions for the return of product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Sterile Sheridan/HVT Cuffed, Murphy Eye,
  • Modèle / numéro de série
    Lot 73F1500606
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.
  • Description du dispositif
    Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. || A tracheal tube is inserted into a patients mouth or nose for airway management.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA