Events

Rappel de TorFlex

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 Baylis Medical Corp *.

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
    66368
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0085-2014
  • Date de publication de l'événement
    2013-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122172
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    The torflex transseptal guiding sheath kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. the particulate could potentially migrate into a patients bloodstream.
  • Action
    Baylis Medical sent an Urgent Device Recall Notification letter dated September 23, 2013, via overnight courier to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the response form provided and fax to 905-602-5671 ATTN: Quality Department to arrange for a free of charge replacement of the affected product. The form requires consignees to return the affected product. For questions contact Quality Assurance at 800-276-4416.

Device

TorFlex
  • Modèle / numéro de série
    Part No. TF8-32-63-135, Lot TFFB070912; Part No.TF8-32-63-37, Lot TFFA310812; Part. No. TF8-32-63-37, Lot TFFB290113; Part No. TF8-32-63-45, Lot TFFA290113; Part No. TF8-32-63-45, Lot TFFB310812; Part No. TF8-32-63-45, Lot TFFC221211; Part No. TF8-32-63-55, Lot TFFA051212; Part No. TF8-32-63-55, Lot TFFA230812; Part No. TF8-32-63-55, Lot TFFB221211; Part No. TF8-32-63-55, Lot TFFB230113; Part No. TF8-32-63-90, Lot TFFA070213; Part No. TF8-32-63-90, Lot TFFA070912; Part No. TF8-32-81-135, Lot TFFH070912; Part No. TF8-32-81-37, Lot TFFD070912; Part No. TF8-32-81-45, Lot TFFE070912; Part No. TF8-32-81-55, Lot TFFF070912; Part No. TF8-32-81-90, Lot TFFG070912; Part No. TF8-38-62-S, Lot TFFA201212; Part No. TF85-32-63-37, Lot TFFC070912; Part No. TF85-32-63-45, Lot TFFA221211; Part No. TF85-32-63-45, Lot TFFA250512; Part No. TF85-32-63-45, Lot TFFC051212; Part No. TF85-32-63-45, Lot TFFC230812; Part No. TF85-32-63-55, Lot TFFA230113; Part No. TF85-32-63-55, Lot TFFA290812; Part No. TF85-32-63-55, Lot TFFB070612; Part No. TF85-32-63-90, Lot TFFB230812; Part No. TF85-32-63-90, Lot TFFC260413; Part No. TF85-32-63-90, Lot TFFC280213; Part No. TF85-32-63-90, Lot TFFF070213; Part No. TF85-32-81-135, Lot TFFC280912; Part No. TF85-32-81-37, Lot TFFA280912; and Part No. TF85-32-81-90, Lot TFFB280912
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of : NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN and the countries of China, Canada, Saudi Arabia, and Italy.
  • Description du dispositif
    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. || Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
  • Manufacturer
    Baylis Medical Corp *

Manufacturer

Baylis Medical Corp *
  • Adresse du fabricant
    Baylis Medical Corp *, 5959 TransCanada Highway, Montreal Canada
  • Société-mère du fabricant (2017)
    Baylis Medical Company, Inc
  • Source
    USFDA