Events

Rappel de Device Recall Beacon Tip Torcon NB Advantage Catheter

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 Cook 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
    71692
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2317-2015
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • Date de publication de l'événement
    2015-08-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138757
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • Cause
    Reports of catheter tip splits and or separation. loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
  • Action
    Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.

Device

Device Recall Beacon Tip Torcon NB Advantage Catheter
  • Modèle / numéro de série
    All Lots of following Product numbers: HNBR4.0-35-100-P-NS-0, HNBR4.0-35-100-P-NS-C1, HNBR4.0-35-100-P-NS-C2, HNBR4.0-35-100-P-NS-CANADA-041480, HNBR4.0-35-100-P-NS-DAV, HNBR4.0-35-100-P-NS-H1, HNBR4.0-35-100-P-NS-JB1,  HNBR4.0-35-100-P-NS-JB2, HNBR4.0-35-100-P-NS-JB3,  HNBR4.0-35-100-P-NS-JIM,  HNBR4.0-35-100-P-NS-KMP,  HNBR4.0-35-100-P-NS-MPA, HNBR4.0-35-100-P-NS-O1,  HNBR4.0-35-100-P-NS-SIM1,  HNBR4.0-35-100-P-NS-SIM2,  HNBR4.0-35-100-P-NS-SIM3, HNBR4.0-35-100-P-NS-VERT,  HNBR4.0-35-100-P-NS-VTK,  HNBR4.0-35-100-P-NS-WNBG,  HNBR4.0-35-125-P-NS-0, HNBR4.0-35-125-P-NS-DAV,  HNBR4.0-35-125-P-NS-H1,  HNBR4.0-35-125-P-NS-JB1,  HNBR4.0-35-125-P-NS-JB2, HNBR4.0-35-125-P-NS-MPA,  HNBR4.0-35-125-P-NS-SIM2,  HNBR4.0-35-125-P-NS-VERT,  HNBR4.0-35-125-P-NS-VTK, HNBR4.0-35-125-P-NS-WNBG,  HNBR4.0-35-40-P-NS-KMP,  HNBR4.0-35-65-P-NS-0,  HNBR4.0-35-65-P-NS-C1, HNBR4.0-35-65-P-NS-C2,  HNBR4.0-35-65-P-NS-C3,  HNBR4.0-35-65-P-NS-DAV,  HNBR4.0-35-65-P-NS-H1,  HNBR4.0-35-65-P-NS-JB1, HNBR4.0-35-65-P-NS-KMP,  HNBR4.0-35-65-P-NS-MPA,  HNBR4.0-35-65-P-NS-RC1,  HNBR4.0-35-65-P-NS-RC2, HNBR4.0-35-65-P-NS-RDC,  HNBR4.0-35-65-P-NS-RIM,  HNBR4.0-35-65-P-NS-SIM1,  HNBR4.0-35-65-P-NS-SIM2, HNBR4.0-35-80-P-NS-C1,  HNBR4.0-35-80-P-NS-C2,  HNBR4.0-35-80-P-NS-JL2,  HNBR4.0-35-80-P-NS-JL2.5, HNBR4.0-35-80-P-NS-JL3,  HNBR4.0-35-80-P-NS-JR1,  HNBR4.0-35-80-P-NS-JR2,  HNBR4.0-35-80-P-NS-JR3.5, HNBR4.0-35-80-P-NS-RH,  HNBR4.0-35-80-P-NS-RLG,  HNBR4.0-35-80-P-NS-VS,  HNBR4.0-35-80-P-NS-VS1, HNBR4.0-35-80-P-NS-VS2,  HNBR4.0-35-80-P-NS-VS3,  HNBR4.0-NT-100-P-NS-H1,  HNBR4.0-NT-80-P-NS-RC1, HNBR4.0-NT-80-P-NS-RIM,  HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0,  HNBR4.1-35-100-P-NS-C1, HNBR4.1-35-100-P-NS-C2,  HNBR4.1-35-100-P-NS-DAV,  HNBR4.1-35-100-P-NS-H1,  HNBR4.1-35-100-P-NS-JB1, HNBR4.1-35-100-P-NS-JB2,  HNBR4.1-35-100-P-NS-JB3,  HNBR4.1-35-100-P-NS-KMP,  HNBR4.1-35-100-P-NS-MPA, HNBR4.1-35-100-P-NS-O1,  HNBR4.1-35-100-P-NS-SIM1,  HNBR4.1-35-100-P-NS-SIM2,  HNBR4.1-35-100-P-NS-SIM3, HNBR4.1-35-100-P-NS-VERT,  HNBR4.1-35-100-P-NS-WNBG,  HNBR4.1-35-110-P-NS-JB1,  HNBR4.1-35-110-P-NS-JB2, HNBR4.1-35-110-P-NS-WNBG,  HNBR4.1-35-120-P-NS-JB2,  HNBR4.1-35-130-P-NS-DAV-T,  HNBR4.1-35-40-P-NS-KMP, HNBR4.1-35-65-P-NS-C1,  HNBR4.1-35-65-P-NS-C2,  HNBR4.1-35-65-P-NS-DAV,  HNBR4.1-35-65-P-NS-H1,  HNBR4.1-35-65-P-NS-JB1, HNBR4.1-35-65-P-NS-KMP,  HNBR4.1-35-65-P-NS-LEV1,  HNBR4.1-35-65-P-NS-MPA,  HNBR4.1-35-65-P-NS-RC1, HNBR4.1-35-65-P-NS-RC2,  HNBR4.1-35-65-P-NS-RDC,  HNBR4.1-35-65-P-NS-RIM,  HNBR4.1-35-65-P-NS-SHK1.0, HNBR4.1-35-65-P-NS-SIM1,  HNBR4.1-35-75-P-NS-CHG-D,  HNBR4.1-35-80-P-NS-C1,  HNBR4.1-35-80-P-NS-C2, HNBR4.1-35-80-P-NS-JL2,  HNBR4.1-35-80-P-NS-JL2.5,  HNBR4.1-35-80-P-NS-JL3,  HNBR4.1-35-80-P-NS-JR1, HNBR4.1-35-80-P-NS-JR2,  HNBR4.1-35-80-P-NS-JR3.5,  HNBR4.1-35-80-P-NS-RC1,  HNBR4.1-35-80-P-NS-RH, HNBR4.1-35-80-P-NS-RLG,  HNBR4.1-35-80-P-NS-VS,  HNBR4.1-35-80-P-NS-VS2,  HNBR4.1-NT-100-P-NS-H1, HNBR4.1-NT-80-P-NS-C1,  HNBR4.1-NT-80-P-NS-RC1,  HNBR4.1-NT-80-P-NS-RH,  HNBR4.1-NT-80-P-NS-RIM, HNBR4.1-NT-80-P-NS-RLG,  HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Description du dispositif
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA